FAST-CUT FSC1620
GUDID 18033959224196
Biopsy needle for automatic gun 16G; 20cm
STERYLAB SRL
End-cut biopsy gun needle| Primary Device ID | 18033959224196 |
| NIH Device Record Key | e74136fd-0886-4046-9870-e26b1232a027 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FAST-CUT |
| Version Model Number | FAST-CUT |
| Catalog Number | FSC1620 |
| Company DUNS | 439659574 |
| Company Name | STERYLAB SRL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08033959224199 [Primary] |
| GS1 | 18033959224196 [Package] Contains: 08033959224199 Package: [25 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051506
FDA Product Code
| KNW | Instrument, Biopsy |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-11 |
| Device Publish Date | 2019-10-02 |
On-Brand Devices [FAST-CUT]
| 18033959224615 | Biopsy needle for automatic gun 20G; 25cm |
| 18033959224585 | Biopsy needle for automatic gun 20G; 20cm |
| 18033959224530 | Biopsy needle for automatic gun 20G; 15cm |
| 18033959224424 | Biopsy needle for automatic gun 18G; 25cm |
| 18033959224387 | Biopsy needle for automatic gun 18G; 20cm |
| 18033959224332 | Biopsy needle for automatic gun 18G; 15cm |
| 18033959224233 | Biopsy needle for automatic gun 16G; 25cm |
| 18033959224196 | Biopsy needle for automatic gun 16G; 20cm |
| 18033959224141 | Biopsy needle for automatic gun 16G; 15cm |
| 18033959220594 | Biopsy needle for automatic gun 14G; 25cm |
| 18033959220587 | Biopsy needle for automatic gun 14G; 20cm |
| 18033959220570 | Biopsy needle for automatic gun 14G; 15cm |
Trademark Results [FAST-CUT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FAST-CUT 74534735 1939365 Dead/Cancelled |
Pennock Corp. 1994-06-07 |
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