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Pds PDP711D

by Ethicon Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

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 Number10705031471979 UDI-DI Date29 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2147-2024 FDA Class II initiated 10 May 2024

    Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Pds
Generic Name
Polyester suture, bioabsorbable, monofilament, antimicrobial
Model / Ref / Catalog
PDP711D
Primary DI / UDI-DI
10705031471979
510(k) Number
FDA Product Code
NEW
GMDN Term
Polyester suture, bioabsorbable, monofilament, antimicrobial
Device Class
Class II
Regulation Number
878.4840
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Related devices

Cleared under the same submission (K212380)

Show all (12)

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Properties

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

Other properties (7)

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