FDA UDI
In Commercial Distribution
🇺🇸 United States
Cytal®
DI: 00386190001103
·
Model: BMM0710
·
ACELL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Cytal®
- Primary DI
- 00386190001103
- Version / Model
- BMM0710
- Catalog Number
- BMM0710
- Company Name
- ACELL, INC.
- Labeler DUNS
- 137258252
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-20
- Public Version
- 9
- Public Version Date
- 2024-02-13
- Public Version Status
- Update
- Public Device Record Key
- 9dcb6a11-849e-4db7-a877-947e2160292a
Device Description
Cytal® Burn Matrix 7 x 10 cm
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- 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 | Collagen wound matrix dressing | A sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00386190001103 | GS1 |
Customer Contacts
- Phone
- +1(800)826-2926
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 7 | Centimeter | |
| Length | 10 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store in a clean, dry environment at room temperature