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Dermaclose GEM204020-K

by Synovis Micro Companies Alliance, Inc 2 variants

Dermaclose GEM204020-K (580100002010) is a skin-closing tension device (FDA Class I; FDA product code MKY, System, Skin Closure) made by Synovis Micro Companies Alliance, Inc, listed in FDA GUDID since 12 Apr 2019 (UDI-DI 00844735006131), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00844735006131 UDI-DI Date12 Apr 2019ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Dermaclose
Generic name
Skin-closing tension device
Model / Ref / Catalog
GEM204020-K, 580100002010
Primary DI / UDI-DI
00844735006131
FDA product code
MKY
GMDN term
Skin-closing tension device
Device class
Class I
Regulation number
878.4320
GUDID distribution status
In Commercial Distribution
Size
Length — 95.25 Centimeter

Related devices

Category: Skin-closing tension device

Similar devices

Other devices filed under FDA product code MKY (SYSTEM, SKIN CLOSURE).

Other devices from Synovis Micro Companies Alliance, Inc

See all devices from Synovis Micro Companies Alliance, Inc →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (7, all answered No)