FDA UDI
In Commercial Distribution
🇺🇸 United States
ProCure
DI: 06973130259027
·
Model: PCHCB002L
·
Anhui Medsport Medical Products Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- ProCure
- Primary DI
- 06973130259027
- Version / Model
- PCHCB002L
- Company Name
- Anhui Medsport Medical Products Co., Ltd.
- Labeler DUNS
- 530104896
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-31
- Public Version
- 1
- Public Version Date
- 2025-09-08
- Public Version Status
- New
- Public Device Record Key
- 2e38ff3a-62b0-4647-9780-f366c1986d11
Device Description
Layer 1 – Foam Padding Bandage 4”x 3.8yds. (10cm x 3.5m) Layer 2 – Compression Bandage 4”x 5.5yds. (10cm x 5m) – stretched. 1roll/Cellophane,2rolls/box,45boxes/carton
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| FQM | Bandage, Elastic | General Hospital | 880.5075 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58964 | Non-adhesive device retention bandage | A piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 06973130259034 | GS1 | carton | 45 | In Commercial Distribution | |
| Primary | 06973130259027 | GS1 |