FDA UDI
In Commercial Distribution
🇺🇸 United States
Wound Free
DI: 00814639025927
·
Model: CWD-0505
·
APPLIED DENTAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Wound Free
- Primary DI
- 00814639025927
- Version / Model
- CWD-0505
- Catalog Number
- CWD-0505
- Company Name
- APPLIED DENTAL, INC.
- Labeler DUNS
- 017524666
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-14
- Public Version
- 1
- Public Version Date
- 2023-04-24
- Public Version Status
- New
- Public Device Record Key
- cb982a00-ed13-462a-bbe4-f84020a4754e
Device Description
WOUND FREE Resorbable Collagen Wound Dressing Pads. 2"x2". Sterile.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 | 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 |
|---|---|---|---|---|---|---|
| Package | 10814639025924 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 00814639025927 | GS1 | ||||
| Package | 20814639025921 | GS1 | case | 40 | In Commercial Distribution |
Customer Contacts
- Phone
- 1-888-841-8481
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius