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GalaFLEX 3D SH3D07BD

by Davol Inc.

GalaFLEX 3D SH3D07BD is a Class II device made by Davol Inc., listed in FDA GUDID since 30 Apr 2026 (UDI-DI 00801741234392), registry data as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801741234392 UDI-DI Date30 Apr 2026ListedStatusListed 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  • Withdrawn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
GalaFLEX 3D
Generic name
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Model / Ref / Catalog
SH3D07BD
Primary DI / UDI-DI
00801741234392
FDA product code
OOD
GMDN term
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe
Size
Width — 7.6 Centimeter
Length — 20.3 Centimeter

Similar devices

Other devices filed under FDA product code OOD (surgical film).

Other devices from Davol Inc.

See all devices from Davol Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)