FDA UDI
In Commercial Distribution
🇺🇸 United States
KerraPro
DI: 05060077230446
·
Model: 4 x 4 x 0.5in
·
CRAWFORD HEALTHCARE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- KerraPro
- Primary DI
- 05060077230446
- Version / Model
- 4 x 4 x 0.5in
- Catalog Number
- KPRO20
- Company Name
- CRAWFORD HEALTHCARE LIMITED
- Labeler DUNS
- 543740310
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-01
- Public Version
- 2
- Public Version Date
- 2020-09-09
- Public Version Status
- Update
- Public Device Record Key
- dcf26d5d-235c-4621-a6e8-fc0b27181e64
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60470 | Pressure-management bandage, silicone | A non-sterile piece of silicone material intended to be worn over pressure-point areas of the body to help prevent the development of, and/or treat, pressure and friction sores in patients with restricted mobility. It is available in various shapes (e.g.,, concave shapes for the heel or elbow, pads for the sacrum, and sheets or strips for other areas of the body) and sizes, and may be used in a healthcare facility or in the home. This is a single-patient, reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060077230392 | GS1 | Carton | 5 | In Commercial Distribution | |
| Primary | 05060077230446 | GS1 | ||||
| Package | 05060077234109 | GS1 | Shipper | 32 | In Commercial Distribution |
Customer Contacts
- Phone
- +4401565654920
- [email protected]
- Phone
- +4401565654920
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Depth | 0.5 | Inch | |
| Length | 4 | Inch | |
| Height | 4 | Inch |