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PrimoCut 415S120100

by Pajunk GmbH Medizintechnologie 4 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04048223126998 UDI-DI Date4 Nov 2025ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
PrimoCut
Generic Name
Side-notch biopsy gun handpiece/needle
Model / Ref / Catalog
415S120100
Primary DI / UDI-DI
04048223126998
510(k) Number
FDA Product Code
MJG
GMDN Term
Side-notch biopsy gun handpiece/needle
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K080674)

Other devices from Pajunk GmbH Medizintechnologie

See all devices from Pajunk GmbH Medizintechnologie →

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