Skip to content

Stratafix SXPN1B407

by Ethicon Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 9 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705031472907 UDI-DI Date29 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 9 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Stratafix
Generic name
Barbed polyolefin/fluoropolymer suture
Model / Ref / Catalog
SXPN1B407
Primary DI / UDI-DI
10705031472907
510(k) Number
FDA product code
GAW
GMDN term
Barbed polyolefin/fluoropolymer suture
Device class
Class II
Regulation number
878.5010
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Cleared under the same submission (K253572)

Show all (12)

Other devices from Ethicon Inc.

See all devices from Ethicon Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • 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