FDA UDI
In Commercial Distribution
🇺🇸 United States
UnnaCare 4x4
DI: 00856525007891
·
Model: ZO1050-00
·
SUN SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- UnnaCare 4x4
- Primary DI
- 00856525007891
- Version / Model
- ZO1050-00
- Catalog Number
- UC4
- Company Name
- SUN SCIENTIFIC, INC.
- Labeler DUNS
- 609397224
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-03-17
- Public Version
- 1
- Public Version Date
- 2023-03-27
- Public Version Status
- New
- Public Device Record Key
- 9cc07e54-b88b-4161-bd68-7a9988e6ab66
- Distribution End Date
- 2030-05-18
Device Description
A 4" x4"sterile or non sterile strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return).it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10284 | Pressure bandage, non-latex, single-use | A strip or roll of fabric or plastic material (non-natural rubber latex) intended to be applied to and compress a local area of the body for one or more preventative/therapeutic applications (e.g., prevent oedema, support injuries associated with minor trauma, treat disorders of venous return). It may be described as a sports tape intended for support while allowing movement, or described as a compression bandage; it is not intended to be used in association with open wounds. It is intended for use in the home or healthcare facility. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00856525007891 | GS1 |
Customer Contacts
- Phone
- 9144795108
- [email protected]