FDA UDI
In Commercial Distribution
🇺🇸 United States
cofoe
DI: 06950715505571
·
Model: KFSZ2080
·
Cofoe Medical Technology Co.,Ltd
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- cofoe
- Primary DI
- 06950715505571
- Version / Model
- KFSZ2080
- Company Name
- Cofoe Medical Technology Co.,Ltd
- Labeler DUNS
- 544425204
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-09
- Public Version
- 1
- Public Version Date
- 2024-12-17
- Public Version Status
- New
- Public Device Record Key
- c52c48c6-9d1e-46be-8a45-86542cdb27ee
Device Description
Cane/Crutch
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IPR | Crutch | Physical Medicine | 890.3150 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31113 | Elbow crutch | A staff-like mobility aid designed to assist a person with a disability to support their weight while walking. The device has one leg, a padded hand support at the level of the user's wrist, and a non-horizontal plastic or metal cuff that wraps around the forearm. The handgrip is typically made of non-slip material (e.g., rubber, glycerin gel, sheepskin). It may be adjustable in length and is typically made of metal [e.g., aluminium (Al), titanium (Ti)]. This device is commonly used by long-term crutch users because of its lightweight and energy preservation qualities. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06950715505571 | GS1 |