FDA UDI
In Commercial Distribution
🇺🇸 United States
Vive
DI: 00810113579870
·
Model: CSH1044BBR
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Vive
- Primary DI
- 00810113579870
- Version / Model
- CSH1044BBR
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-24
- Public Version
- 1
- Public Version Date
- 2024-11-01
- Public Version Status
- New
- Public Device Record Key
- 20c69fb4-c15f-4706-9adb-08655b2b5cd7
Device Description
Crutch Pads (Black Brushed)
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| INP | Tips And Pads, Cane, Crutch And Walker | Physical Medicine | 890.3790 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11062 | Crutch pad | A formed piece of non-slip material (e.g., rubber, glycerin gel, sheepskin) designed to be attached to a part of a crutch to enable firm and comfortable support during use of the crutch, e.g., for use with an axillary crutch or elbow crutch. A crutch will typically be initially provided with the necessary padding, this meaning that this GMDN code serves products meant as replacement parts or for additional crutch padding. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810113579877 | GS1 | Case | 80 | In Commercial Distribution | |
| Primary | 00810113579870 | GS1 |