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HandCut PM1615

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

Listed FDA GUDID listing, no authorization on record

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 Number08056138586185 UDI-DI Date14 May 2021ListedStatusListed GUDID: 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  • Withdrawn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
PM1615
Primary DI / UDI-DI
08056138586185
FDA Product Code
MJG
GMDN Term
Soft-tissue biopsy procedure kit, non-medicated
Device Class
Class I
Regulation Number
878.4800
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 150 Millimeter
Needle Gauge — 16 Gauge

Related devices

Category: Soft-tissue biopsy procedure kit, non-medicated

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

See all devices from M.D.L. S.R.L. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

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