FDA UDI
In Commercial Distribution
🇺🇸 United States
Cutimed® Epiona®
DI: 04250569302015
·
Model: 73227-03
·
BSN medical GmbH
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
10
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Basic Information
- Brand Name
- Cutimed® Epiona®
- Primary DI
- 04250569302015
- Version / Model
- 73227-03
- Catalog Number
- 73227-03
- Company Name
- BSN medical GmbH
- Labeler DUNS
- 342651662
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-07-01
- Public Version
- 2
- Public Version Date
- 2025-07-21
- Public Version Status
- Update
- Public Device Record Key
- 0e21ddd7-ec69-4708-9026-b105cc47d32d
Device Description
CUTIMED EPIONA STERILE 5CMX5CM WHITE 10 USA 2X2"
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
- Yes
- 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 | Wound Dressing With Animal-Derived Material(S) | 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 | 04250569302022 | GS1 | 5 | In Commercial Distribution | ||
| Primary | 04250569302015 | GS1 | ||||
| Unit of Use | 04250569302008 | GS1 | ||||
| Previous | 04042809433760 | GS1 |
Customer Contacts
- Phone
- +1(800)537-1063
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5 | Centimeter | |
| Width | 5 | Centimeter |