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Device Explorer · FDA GUDID · GMDN 33873

Skin-closing tension device

A sterile device designed to apply continuous tension to an area of skin to stretch it to achieve a surplus of full thickness skin and subcutaneous tissue for the closure of a wound where the margins are too far apart for suturing, or prior to the surgical exc

US‑registered devices66in commercial distribution
Companies8labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription52%Rx‑only share
ImplantableYesGMDN flag
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Share of device records

Meril Endo Surgery Private Limited1523%
I.V.T. Medical Ltd1320%
Southmedic Incorporated1218%
Healthium Medtech Limited1117%
Dfix711%
Synovis Micro Companies Alliance, Inc69%
Henan Huibo Medical Co.,Ltd.12%
Suturegard Medical, Inc12%

Top labelers

CompanyDevicesShare
Meril Endo Surgery Private Limited1523%
I.V.T. Medical Ltd1320%
Southmedic Incorporated1218%
Healthium Medtech Limited1117%
Dfix711%
Synovis Micro Companies Alliance, Inc69%
Henan Huibo Medical Co.,Ltd.12%
Suturegard Medical, Inc12%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

TopClosureHuibo MedicalSUTUREGARD® InterlockDERMACLOSEDynamic Tissue Systems™MEGASORBTruglydePolyglycolic acidTRUGLYDEDIALFIX PLUS 5DIALFIX PLUS 3DIALFIX 24DIALFIX 21DIALFIX 18DIALFIX 15DIALFIX 11

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

FDA product codes

CodeNameDevices
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid26
MKYSystem, Skin Closure22
MKYSYSTEM, SKIN CLOSURE6
KGSRETENTION DEVICE, SUTURE4
LROGeneral surgery tray4
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE2

GMDN & GCC registration

  • GMDN code 33873 · implantable
  • Single‑use 100% · sterile 100% · Rx‑only 52% · 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 (Centimeter) · 2

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

No closely related category with 50+ devices.

How many skin-closing tension device products are registered in the US?

66 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Skin-closing tension device", from 8 companies. The largest labeler is Meril Endo Surgery Private Limited with 23% of records.

Which FDA product codes apply?

GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), MKY (System, Skin Closure), MKY (SYSTEM, SKIN CLOSURE), KGS (RETENTION DEVICE, SUTURE)

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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