FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Palium Needle
DI: 08052440103003
·
Model: MGK11615
·
M.D.L. S.R.L.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Palium Needle
- Primary DI
- 08052440103003
- Version / Model
- MGK11615
- Catalog Number
- MGK11615
- 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
- 27000222-f721-4f48-925a-21181391a1aa
- Distribution End Date
- 2021-04-26
Device Description
DISPOSIBLE NEEDLE FOR SOFT TISSUE BIOPSY 16G x 150 mm COMPATIBLE WITH BARD ® AUTOMATIC MAGNUM ® GUN AND PALIUM GUN
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 |
|---|---|---|---|---|
| 64327 | End-cut biopsy gun needle | An invasive tubular surgical instrument designed to be connected to a biopsy gun handpiece (not included) for the automatic extraction of a core tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is an open, cylindrical needle intended to be percutaneously inserted, typically under image guidance, and is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08052440103003 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 16 | Gauge | |
| Length | 150 | Millimeter |