FDA UDI
In Commercial Distribution
🇺🇸 United States
PAC-UF
DI: 08033959222003
·
Model: PAC-UF
·
STERYLAB SRL
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PAC-UF
- Primary DI
- 08033959222003
- Version / Model
- PAC-UF
- Catalog Number
- PACUF1020
- Company Name
- STERYLAB SRL
- Labeler DUNS
- 439659574
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-03
- Public Version
- 2
- Public Version Date
- 2025-03-06
- Public Version Status
- Update
- Public Device Record Key
- f6c38150-a338-4fb2-9ef4-d4acf0927e19
Device Description
Reusable pistol for cytological aspiration
Device Characteristics
- Single Use
- No
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNW | Instrument, Biopsy | Gastroenterology, Urology | 876.1075 | 2 |
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64326 | Biopsy gun handpiece, mechanical | A hand-operated, non-electronic, surgical instrument designed to be used with a dedicated disposable biopsy gun needle (not included) for the automatic extraction of a soft-tissue sample from an anatomical structure (a biopsy), while causing minimal surrounding tissue damage, for tissue pathological examination/testing. It has a spring-loaded mechanism with a release trigger intended to accept and operate the cutting mechanism of a percutaneous biopsy needle. 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08033959222003 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K051506 | 000 |