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Peco PU008

by Peco Medical Inc. GUDID

Withdrawn United States

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10817668010015 UDI-DIDate8 Sep 2017ListedStatusWithdrawn

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Peco
Generic Name
Single-administration urethral drainage catheter
Model / Reference
PU008
Primary DI / UDI-DI
10817668010015
510(k) Number
FDA Product Code
GBM
GMDN Term
Single-administration urethral drainage catheter
Device Class
Class II
Regulation Number
876.5130
Commercial Distribution
Not in Commercial Distribution
Sterilization Method
Ethylene Oxide
Size
Length — 10 Inch
Catheter Gauge — 8 French

Related devices

Cleared under the same submission (K111405)

Show all (12)

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number

Other properties (11)

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