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GalaFLEX 3D SH3D04BD

by Davol Inc.

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10801741234368 UDI-DI Date30 Apr 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
SH3D04BD
Primary DI / UDI-DI
10801741234368
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 — 6.4 Centimeter
Length — 18.5 Centimeter

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No