FDA UDI
Not in Commercial Distribution
🇺🇸 United States
HandCut
DI: 08052440105670
·
Model: PM1410
·
M.D.L. S.R.L.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- HandCut
- Primary DI
- 08052440105670
- Version / Model
- PM1410
- Catalog Number
- PM1410
- Company Name
- M.D.L. S.R.L.
- Labeler DUNS
- 447228586
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-04-26
- Public Version
- 2
- Public Version Date
- 2021-05-27
- Public Version Status
- Update
- Public Device Record Key
- c60892dc-b7c2-4b99-9e8b-1a8780a119f5
- Distribution End Date
- 2021-04-26
Device Description
DISPOSABLE NEEDLE FOR SOFT TISSUE BIOPSY WITH MANUAL ACTION 14G x 100 mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MJG | Device, Percutaneous, Biopsy | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16835 | Soft-tissue biopsy procedure kit, non-medicated | A collection of sterile devices designed to perform a non-specific soft tissue biopsy. It includes the biopsy needle used for this procedure; it does not include a pharmaceutical. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08052440105670 | GS1 |