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Device Explorer · FDA GUDID · GMDN 35257

Vascular booties

"A sterile cover, used in pairs, fitted onto the distal working end (the jaws) of artery forceps, vascular clamps, or similar surgical instruments, to provide improved grip for delicate sutures. It is typically tube-like with a closed, rounded tip and composed

US‑registered devices135in commercial distribution
Companies9labelers on GUDID
Single‑use70%of device records
Sterile37%labelled sterile
Prescription59%Rx‑only share
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Share of device records

Sontec Instruments, Inc.3929%
Aspen Surgical Products, Inc.3324%
Scanlan International Inc2821%
Batrik Medical Manufacturing Inc1813%
Deroyal Industries, Inc.118%
Key Surgical, Inc.21%
Axiom Medical, Incorporated21%
Medtronic Sofamor Danek, Inc.11%

Top labelers

CompanyDevicesShare
Sontec Instruments, Inc.3929%
Aspen Surgical Products, Inc.3324%
Scanlan International Inc2821%
Batrik Medical Manufacturing Inc1813%
Deroyal Industries, Inc.118%
Key Surgical, Inc.21%
Axiom Medical, Incorporated21%
Medtronic Sofamor Danek, Inc.11%
Medline Industries, Inc.11%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Key Surgical Suture BootiesScanlan® SURG-I-PAW® Instrument CoversScanlan® SUTURE-STATT® suture tagsScanlan® SOFT GRIP™ Fabric Instrument CoversSCANLAN® Pincap® orthopedic pin protectorsScanlan® SUTURE BOOT™ Instrument Jaw CoversSterion®Suture BootsSterion®Suture Aid BootiesMedical Action 5 Pair Yellow Suture BootiesMedical Action 5 Pair Assorted Suture BootiesDeRoyalSuture Clamp Tags, SterileBatrik Suture Tags Pink 5 pairsBatrik Suture Clamp TagsBatrik Suture Tags Blue 5 pairsBatrik Suture Tags White 5 Pairs

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
KDCINSTRUMENT, SURGICAL, DISPOSABLE47
KDCInstrument, Surgical, Disposable42
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE32
GDJClamp, Surgical, General & Plastic Surgery14
MDMInstrument, Manual, Surgical, General Use7
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY3

GMDN & GCC registration

  • GMDN code 35257 · non‑implantable
  • Single‑use 70% · sterile 37% · Rx‑only 59% · OTC 1%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Inch) · 10Lumen/Inner Diameter (Inch) · 9Length (Millimeter) · 9Depth (Millimeter) · 8Width (Millimeter) · 3

Use these as the dimensions to specify in a tender line.

How many vascular booties products are registered in the US?

135 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Vascular booties", from 9 companies. The largest labeler is Sontec Instruments, Inc. with 29% of records.

Which FDA product codes apply?

KDC (INSTRUMENT, SURGICAL, DISPOSABLE), KDC (Instrument, Surgical, Disposable), MDM (INSTRUMENT, MANUAL, SURGICAL, GENERAL USE), GDJ (Clamp, Surgical, General & Plastic Surgery)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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