| Primary Device ID | 00857425005666 |
| NIH Device Record Key | 7aab127d-6826-443b-913a-5755162f8683 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Select Choice |
| Version Model Number | GAU3300 |
| Company DUNS | 009046405 |
| Company Name | Hemasource, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857425005666 [Primary] |
| GS1 | 10857425005663 [Package] Package: Box [50 Units] In Commercial Distribution |
| GS1 | 20857425005660 [Package] Contains: 10857425005663 Package: Case [30 Units] In Commercial Distribution |
| NAB | Gauze / Sponge,Nonresorbable For External Use |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
[00857425005666]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-11-07 |
| Device Publish Date | 2022-12-08 |
| 00810045480480 | Exam Glove Nitrile P-Free Select Choice XL 3000/case |
| 00810045480459 | Exam Glove Nitrile P-Free Select Choice LG 3000/case |
| 00810045480428 | Exam Glove Nitrile P-Free Select Choice MD 3000/case |
| 00810045480398 | Exam Glove Nitrile P-Free Select Choice SM 3000/case |
| 00810045480367 | Exam Glove Nitrile P-Free Select Choice XS 3000/case |
| 00857425005666 | Select Choice 2" 4 Ply Sterile, Non woven Sponge |
| 10857425005632 | Select Choice 2" 4 Ply Non Sterile, Non woven Sponge |