| Primary Device ID | 00850048866157 |
| NIH Device Record Key | 9dbd6a6b-c96e-4873-9fa4-8bbf0ef6ada9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SkinTemp II |
| Version Model Number | ST1002 |
| Company DUNS | 014511541 |
| Company Name | Human Biosciences Inc. |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00850048866089 [Primary] |
| GS1 | 00850048866157 [Package] Contains: 00850048866089 Package: Box [5 Units] In Commercial Distribution |
| KGN | Wound Dressing With Animal-Derived Material(S) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-27 |
| Device Publish Date | 2023-06-19 |
| 00850048866171 | SkinTemp sterile collagen wound dressing, 8x12 sheet |
| 00850048866164 | SkinTemp sterile collagen wound dressing, 7x7 sheet |
| 00850048866140 | SkinTemp sterile collagen wound dressing, 2x2 sheet |
| 00850048866157 | SkinTemp sterile collagen wound dressing, 3x4 sheet |