Identity
- Trade Name
- DANA 2.2 MG G FDA UDI
- Generic Name
- Biopsy gun handpiece, mechanical FDA UDI
- Device Name
- Automatic Biopsy Gun for Soft tissue Biopsy Needles FDA UDI
- Model / Reference
- 22 mm FDA UDI
- Description
- Automatic Biopsy Gun for Soft tissue Biopsy Needles FDA UDI
Identifiers
- Catalog Number
- 360015 FDA UDI
- Primary DI / UDI-DI
- G635360015 FDA UDI
- FDA Product Code
- DWO FDA UDI
- GMDN Term
- Biopsy gun handpiece, mechanical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Biopsy gun handpiece, mechanical
Dana 2.2 Mg G by Histo S.a. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Biopsy gun handpiece, mechanical.
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- PAC — STERYLAB SRL · Class II
- Palium — M.D.L. S.R.L. · Class II
- DANA 2.2 MG G — HISTO S.A. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Histo S.a.
Sources (1)
- FDA UDI 2537645c-cd83-4583-a3cd-9c10e81c2371 36 fields · synced Jun 8, 2026