FDA UDI
Not in Commercial Distribution
🇺🇸 United States
TIDI
DI: 00618125174553
·
Model: VMR38X01
·
TIDI PRODUCTS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TIDI
- Primary DI
- 00618125174553
- Version / Model
- VMR38X01
- Company Name
- TIDI PRODUCTS, LLC
- Labeler DUNS
- 063519193
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-15
- Public Version
- 3
- Public Version Date
- 2023-03-07
- Public Version Status
- Update
- Public Device Record Key
- 7a192404-64de-4a1b-aebc-a86f52b4167f
- Distribution End Date
- 2023-03-06
Device Description
Med-Vac Patient Positioners Child 1 per Each
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- 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
- 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 |
|---|---|---|---|---|
| FZF | Splint, Extremity, Inflatable, External | General, Plastic Surgery | 878.3900 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35358 | Vacuum mouldable splint | A non-sterile device designed to immobilize and protect an injured body part during the healing process. Immobilization is achieved by placing the device around the body part and then withdrawing air from the device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00618125174553 | GS1 |