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Tuohy II 1170-6O081

by Pajunk GmbH Medizintechnologie

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04048223122792 UDI-DI Date22 Oct 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Tuohy II
Generic Name
Epidural needle, non-threaded
Model / Ref / Catalog
1170-6O081
Primary DI / UDI-DI
04048223122792
510(k) Number
FDA Product Code
BSP
GMDN Term
Epidural needle, non-threaded
Device Class
Class II
Regulation Number
868.5150
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Needle Gauge — 16.0 Gauge
Length — 80.0 Millimeter

Related devices

Cleared under the same submission (K160297)

Show all (12)

Other devices from Pajunk GmbH Medizintechnologie

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (9)

  • 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