FDA UDI
In Commercial Distribution
🇺🇸 United States
Vive
DI: 00810113577579
·
Model: SUP3070BLKS
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Vive
- Primary DI
- 00810113577579
- Version / Model
- SUP3070BLKS
- Company Name
- VIVE HEALTH LLC
- Labeler DUNS
- 047025993
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-08-16
- Public Version
- 1
- Public Version Date
- 2024-08-26
- Public Version Status
- New
- Public Device Record Key
- b903e05b-ebcf-4c62-b999-9289e27fb12b
Device Description
Achilles Wedge (Small)
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 |
|---|---|---|---|---|
| ITW | Joint, Ankle, External Brace | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58504 | Geometric shape exerciser | A physical training and rehabilitation device in various geometric shapes designed to be placed on the floor to support a patient?s body while performing gymnastic movements to regain and/or improve body movement and balance, and/or for strengthening the limbs and the trunk of the body; some types may provide a motion (e.g., rocking). It is typically used by a person with a physical disability/disorder. It is available in various shapes (e.g., cylindrical, square, oblong or curved) and sizes and typically consists of polyurethane foam covered with high-density non-slip, waterproof, washable polyvinyl chloride (PVC) fabrics. The device may be available in a set of different shapes and sizes. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810113577576 | GS1 | Case | 72 | In Commercial Distribution | |
| Primary | 00810113577579 | GS1 |