Celluheal
GUDID 00850048866300
Cellusheet sterile collagen wound dressing, 2x2 sheet
Human Biosciences Inc.
Collagen wound matrix dressing| Primary Device ID | 00850048866300 |
| NIH Device Record Key | 2365505e-a125-4d83-ac2a-7625a5be0a64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Celluheal |
| Version Model Number | CS1022 |
| 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 | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850048866034 [Primary] |
| GS1 | 00850048866300 [Package] Contains: 00850048866034 Package: Box [5 Units] In Commercial Distribution |
FDA Product Code
| KGN | Wound Dressing With Animal-Derived Material(S) |
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 | 2023-10-06 |
| Device Publish Date | 2023-09-28 |
On-Brand Devices [Celluheal]
| 00850048866041 | Cellufil sterile collagen particles, 1 gram pouch |
| 00850048866300 | Cellusheet sterile collagen wound dressing, 2x2 sheet |
| 00850048866959 | SkinTemp sterile collagen wound dressing, 5x10 sheet |
Trademark Results [Celluheal]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CELLUHEAL 98085172 not registered Live/Pending |
Human Biosciences, Inc. 2023-07-14 |
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