FDA UDI
In Commercial Distribution
🇺🇸 United States
Zimmer Tourniquet
DI: 00816317023300
·
Model: RM-60707500200
·
RENU MEDICAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Zimmer Tourniquet
- Primary DI
- 00816317023300
- Version / Model
- RM-60707500200
- Company Name
- RENU MEDICAL, INC
- Labeler DUNS
- 100439103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-06-16
- Public Version
- 5
- Public Version Date
- 2023-09-08
- Public Version Status
- Update
- Public Device Record Key
- c545e0e5-6d51-4e20-9d85-f5c908027cbf
Device Description
Zimmer Tourniquet 12 inch
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| KCY | Tourniquet, Pneumatic | General, Plastic Surgery | 878.5910 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61824 | Oral Candida wipe | A 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 intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10816317023307 | GS1 | case | 10 | In Commercial Distribution | |
| Primary | 00816317023300 | GS1 |