Primary Device ID | 56971227400371 |
NIH Device Record Key | 566003bd-1ea3-4b93-ac7d-87c2283e33f3 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Assure® ID Safety Pen Needle |
Version Model Number | SPN-30-8 |
Company DUNS | 421335278 |
Company Name | Promisemed Hangzhou Meditech Co., Ltd. |
Device Count | 100 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
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 Issuing Agency | Device ID |
---|---|
GS1 | 16971227400373 [Unit of Use] |
GS1 | 36971227400377 [Primary] |
GS1 | 56971227400371 [Package] Contains: 36971227400377 Package: carton [12 Units] In Commercial Distribution |
Steralize Prior To Use | true |
Device Is Sterile | true |
[56971227400371]
Radiation Sterilization
[56971227400371]
Radiation Sterilization
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2018-01-12 |
56971227400395 | The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl |
36971227400384 | The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl |
56971227400371 | The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and singl |