FDA UDI
In Commercial Distribution
🇺🇸 United States
CoreTech
DI: 00810113578323
·
Model: SUP3035BLK4XL
·
VIVE HEALTH LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- CoreTech
- Primary DI
- 00810113578323
- Version / Model
- SUP3035BLK4XL
- 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
- 3
- Public Version Date
- 2025-11-20
- Public Version Status
- Update
- Public Device Record Key
- f445989e-be30-4c0e-8829-5497ec1850f5
Device Description
SAFS (Shorts Against FAI Syndrome) 4XL
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 |
|---|---|---|---|---|
| ITJ | Walker, Mechanical | Physical Medicine | 890.3825 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45606 | Compression/pressure shirt/pants | A garment in the form of a vest, shirt, pants, leggings, girdle, or whole-body suit intended to tightly fit over, and apply compression/pressure (i.e., graduated or even-force) to, an area of the upper and/or mid/lower body to support skin/subcutaneous healing and scar prevention, to exude excessive interstitial fluid, and/or to help improve proprioception. Designed to be worn around the hips and/or shoulders, it is neither a strip/roll binder, limb sleeve, glove, nor sock. It is not intended to come into direct contact with, or to manage/treat, open wounds, injured skin, or infectious or infection-susceptible skin conditions. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10810113578320 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00810113578323 | GS1 |