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Device Explorer · FDA GUDID · GMDN 59870

Open-surgery manual linear cutting stapler, single-use

A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operate

US‑registered devices64in commercial distribution
Companies5labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription75%Rx‑only share
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Share of device records

Ethicon Endo-Surgery, Llc2844%
Covidien Lp1422%
B. J. Zh. F. Panther Medical Equipment Co., Ltd.1320%
Meril Endo Surgery Private Limited69%
Sinolinks Medical Innovation Co., Ltd.35%

Top labelers

CompanyDevicesShare
Ethicon Endo-Surgery, Llc2844%
Covidien Lp1422%
B. J. Zh. F. Panther Medical Equipment Co., Ltd.1320%
Meril Endo Surgery Private Limited69%
Sinolinks Medical Innovation Co., Ltd.35%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Disposable Linear Cutter Staplers and ReloadsDisposable Curved Cutter Staplerscutter staplerReloading Unit for Linear Cutter StaplerLinear Cutter StaplerGIARoticulatorEchelon Linear CutterPROXIMATEProximateCONTOURContour TranstarN/AMirusTM Linear Cutter Reload

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

FDA product codes

CodeNameDevices
GDWSTAPLE, IMPLANTABLE46
GDWStaple, Implantable23
GAGStapler, surgical16
GDWStaple, implantable7
FTLMesh, Surgical, Polymeric1

GMDN & GCC registration

  • GMDN code 59870 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 75% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Length (Millimeter) · 25Height (Millimeter) · 13Height (Inch) · 5

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

How many open-surgery manual linear cutting stapler, single-use products are registered in the US?

64 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Open-surgery manual linear cutting stapler, single-use", from 5 companies. The largest labeler is Ethicon Endo-Surgery, Llc with 44% of records.

Which FDA product codes apply?

GDW (STAPLE, IMPLANTABLE), GDW (Staple, Implantable), GAG (Stapler, surgical), GDW (Staple, implantable)

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.

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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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