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Deknatel IPN012361

by Teleflex Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number04026704592135 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1017-2007 FDA Unclassified (pre-2012) initiated 6 Jun 2007 on shared 510(k) K001440

    Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

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  • Withdrawn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
Deknatel
Generic Name
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobial
Model / Ref / Catalog
IPN012361, F7-113C9K
Primary DI / UDI-DI
04026704592135
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
MRI Safety
MR Safe
Size
Length — 75 Centimeter

Related devices

Category: Polyester suture, non-bioabsorbable, multifilament

Cleared under the same submission (K001440)

Show all (12)

Other devices from Teleflex Incorporated

See all devices from Teleflex Incorporated →

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