Pen Needle
GUDID 00369771003390
Safety Pen Needle 30G
GERI-GENTLE CORPORATION
Subcutaneous infusion/injection port needle| Primary Device ID | 00369771003390 |
| NIH Device Record Key | 2867576c-1005-46ea-a9be-c68a923f40e9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pen Needle |
| Version Model Number | 11-305 |
| Company DUNS | 361663839 |
| Company Name | GERI-GENTLE CORPORATION |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00369771003390 [Primary] |
| GS1 | 00369771003406 [Package] Package: inner [100 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192677
FDA Product Code
| FMI | Needle, Hypodermic, Single Lumen |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-11 |
| Device Publish Date | 2023-09-01 |
Devices Manufactured by GERI-GENTLE CORPORATION
| 00369771003659 - Sharps Collector 5QT | 2023-11-09 Sharps Collector 5QT |
| 00369771003390 - Pen Needle | 2023-09-11Safety Pen Needle 30G |
| 00369771003390 - Pen Needle | 2023-09-11 Safety Pen Needle 30G |
| 00369771003437 - Prefilled Syrings | 2023-09-11 10ML PREFILLED SYRINGE |
| 00369771003161 - Oxygen Concentrator | 2023-08-09 Oxygen Concentrator |
| 20369771000782 - Lancets Safety | 2023-08-09 Lancets Safety |
| 00369771003123 - SYRINGE RETRACT U100 1cc 29x.5 | 2023-07-10 SYRINGE RETRACT U100 1cc 29x.5 |
| 20369771000898 - Syringes Safety | 2023-02-22 SYR U100 1cc 29x.5 |
| 20369771000904 - Syringes Safety | 2023-02-22 SYR U100 .5cc 29x.5 |
Trademark Results [Pen Needle]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PEN NEEDLE 87159412 not registered Dead/Abandoned |
Ko Pen Wang, MD 2016-09-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.