Pen Needle 320617
GUDID 50382903206174
PN RELION 31G X 6MM 3B TW 50CT
Suzhou BD Medical Device Co., Ltd
Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle| Primary Device ID | 50382903206174 |
| NIH Device Record Key | b8b42c23-b6f6-4588-9144-a6fddaafc68f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pen Needle |
| Version Model Number | 681131386807 |
| Catalog Number | 320617 |
| Company DUNS | 420025124 |
| Company Name | Suzhou BD Medical Device Co., Ltd |
| Device Count | 50 |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Dimensions
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
Operating and Storage Conditions
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 4 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681131386807 [Primary] |
| GS1 | 50382903206174 [Package] Contains: 00681131386807 Package: Case [18 Units] In Commercial Distribution |
| GS1 | 80382903206175 [Unit of Use] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K162516
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 | 2022-10-18 |
| Device Publish Date | 2022-10-10 |
On-Brand Devices [Pen Needle]
| 50382903206174 | PN RELION 31G X 6MM 3B TW 50CT |
| 50382903206181 | PN 31G X 8MM 3B TW 50CT |
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 |
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