Zimmer Tourniquet
- Primary DI
- 10816317023307
- Brand
- Zimmer Tourniquet
- Company
- RENU MEDICAL, INC
- Model
- RM-60707500200
- Device description
- Zimmer Tourniquet 12 inch
- Published
- 2017-06-16
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- true
Related Records
Product Codes
| Code | Name |
|---|---|
| KCY | Tourniquet, Pneumatic |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|---|---|---|
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10816317023307 | Package | GS1 | 10 | In Commercial Distribution |
| 00816317023300 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10816317023307 | 10816317023307 | ||
| 00816317023300 | 00816317023300 | 816317023300 | 0816317023300 |
GMDN Terms
| Term | Definition |
|---|---|
| Oral Candida wipe | A non-sterile fabric pad pre-soaked in a solution of plant-derived compounds (e.g., calendula extracts) intended for mechanical cleaning of the oral mucosa infected by Candida albicans (thrush), and to create an unfavourable environment for microbial growth. It is normally available over-the-counter (OTC) for use in the home. This is a single-use device. |
Sterilization Methods
| Method |
|---|
Regulatory Flags
- DUNS number
- 100439103
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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