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HandCut PM16114

by M.D.L. S.R.L. 2 variants

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number08032986359102 UDI-DI Date4 Jan 2017ListedStatusListed GUDID: not in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
HandCut
Generic Name
Soft-tissue biopsy procedure kit, non-medicated
Model / Ref / Catalog
PM16114
Description
CS 10 - DISPOSABLE NEEDLE 16Gx114mm FOR SOFT TISSUE BIOPSY WITH MANUAL ACTION
Primary DI / UDI-DI
08032986359102
FDA Product Code
MJG
GMDN Term
Soft-tissue biopsy procedure kit, non-medicated
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
Not in Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 114 Millimeter
Needle Gauge — 16 Gauge

Other devices from M.D.L. S.R.L.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No