FDA UDI
In Commercial Distribution
🇺🇸 United States
Tex-Care Medical
DI: 00632195000581
·
Model: 91861-204
·
Flynt/Amtex, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tex-Care Medical
- Primary DI
- 00632195000581
- Version / Model
- 91861-204
- Company Name
- Flynt/Amtex, Inc.
- Labeler DUNS
- 038730060
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-29
- Public Version
- 1
- Public Version Date
- 2021-11-08
- Public Version Status
- New
- Public Device Record Key
- d1f9d901-e57a-4a70-952b-e602ecd57134
Device Description
2"X4YD SYN CAST PAD BULK PA
Device Characteristics
- Single Use
- Yes
- 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
- No
- 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
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Radiation Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LGF | Component, Cast | Orthopedic | 888.5940 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 10669 | Cast stockinette | A knitted, seamless tube of material, typically cotton, designed to stretch and fit any contour of the body. It is typically used as padding under a cast or splint. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00632195000581 | GS1 |