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PTFE Polymer Pledgets VPG36SE

by Covidien LP

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

6 closed

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 Number10884521550698 UDI-DI Date26 May 2017ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-2827-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2826-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2830-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2825-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2828-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591
    • Terminated Z-2829-2011 FDA Unclassified (pre-2012) initiated 3 Jun 2011 on shared 510(k) K930591

    Potential for the sterile barrier to be breached compromising the sterility of the product

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PTFE Polymer Pledgets
Generic Name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / Reference
VPG36SE
Primary DI / UDI-DI
10884521550698
510(k) Number
FDA Product Code
GAT
GMDN Term
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Device Class
Class II
Regulation Number
878.5000
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Cleared under the same submission (K930591)

Show all (12)

Other devices from Covidien LP

See all devices from Covidien LP →

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