FDA UDI
In Commercial Distribution
🇺🇸 United States
Vitale
DI: 00850065122014
·
Model: 22010
·
CELLERA LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Vitale
- Primary DI
- 00850065122014
- Version / Model
- 22010
- Catalog Number
- 22010
- Company Name
- CELLERA LLC
- Labeler DUNS
- 960091929
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-04-11
- Public Version
- 2
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- 560be504-034a-451d-b02f-9e0f6d387154
Device Description
Vitale Collagen Dressings, 5" x 10", 10/box, 10 boxes/case
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGN | Dressing, Wound, Collagen | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45023 | Animal-derived wound matrix dressing | A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00850065122021 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00850065122014 | GS1 | ||||
| Package | 10850065122028 | GS1 | Case | 10 | In Commercial Distribution |
Customer Contacts
- Phone
- 800-892-2391
- [email protected]