FDA UDI
In Commercial Distribution
🇺🇸 United States
PremierPro
DI: 00818566017239
·
Model: 7034B
·
PRESTIGE AMERITECH, LTD.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- PremierPro
- Primary DI
- 00818566017239
- Version / Model
- 7034B
- Catalog Number
- 7034B
- Company Name
- PRESTIGE AMERITECH, LTD.
- Labeler DUNS
- 199692794
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-08-29
- Public Version
- 2
- Public Version Date
- 2026-03-23
- Public Version Status
- Update
- Public Device Record Key
- bf2426bc-7271-4021-a917-c559c6f68ca0
Device Description
Fiberglass Cast Tape, 4" x 4 yards, Blue, 10 rolls
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ITG | Bandage, Cast | Physical Medicine | 890.3025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33056 | Cast construction material | A plastic, fibreglass, or plaster-containing substance (or other material) that is applied in layers around an injured body appendage to construct a stiff dressing (cast) in order to immobilize fractured bones, diseased joints, or painful sprains. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00818566017239 | GS1 |
Customer Contacts
- Phone
- 1-855-531-7699
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Avoid Direct Sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 25 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry