FDA UDI
In Commercial Distribution
🇺🇸 United States
VACU-CUT®
DI: 00801741083884
·
Model: 17620080
·
Angiomed GmbH & Co. Medizintechnik KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- VACU-CUT®
- Primary DI
- 00801741083884
- Version / Model
- 17620080
- Catalog Number
- 17620080
- Company Name
- Angiomed GmbH & Co. Medizintechnik KG
- Labeler DUNS
- 320047483
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-06
- Public Version
- 3
- Public Version Date
- 2024-01-04
- Public Version Status
- Update
- Public Device Record Key
- 9693a71c-b0a6-42e6-8ad4-47d09602ee0b
Device Description
VACU-CUT® Disposable Aspiration Biopsy Needle 19.5g x 200mm
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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GAA | NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64328 | Side-notch 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 small tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It is a percutaneously-inserted needle with a side-notch cutter at the distal end which when activated causes a sharp, sliding cannula to slice a segment of tissue. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10801741083881 | GS1 | CA | 10 | In Commercial Distribution | |
| Primary | 00801741083884 | GS1 |
Customer Contacts
- Phone
- +4972194450
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 19.5 | Gauge | |
| Length | 200 | Millimeter |