FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 00889024377080
·
Model: 60-7070-101-00
·
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 00889024377080
- Version / Model
- 60-7070-101-00
- Catalog Number
- 60-7070-101-00
- Company Name
- ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
- Labeler DUNS
- 137354267
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-02
- Public Version
- 1
- Public Version Date
- 2021-11-10
- Public Version Status
- New
- Public Device Record Key
- f4a427b9-5f27-4059-92a2-3a7c976f73fa
Device Description
ZIMMER® STERILE DISPOSABLE TOURNIQUET CUFF WITH PLC, DUAL PORT, SINGLE BLADDER, 8 IN. (20 CM)
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 35952 | Helicopter ambulance | A helicopter designed (modified and equipped) for use by emergency medical services (EMS) to transport the sick or wounded, especially as a rapid alternative to ground transport around urban areas or during military operations. It will carry onboard equipment for emergency treatment and to maintain or improve the clinical status of the patient, such as devices for carrying or supporting a patient (e.g., stretchers, splints), oxygen therapy (e.g., oxygen cylinders and tubing), intubation/chest decompression (tubes), bleeding control (e.g., bandages, tourniquets), cardioversion/defibrillation (defibrillators), and patient monitoring. It may also carry tools to help extricate a trapped patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00889024380554 | GS1 | Shelf Carton | 5 | In Commercial Distribution | |
| Primary | 00889024377080 | GS1 | ||||
| Package | 00889024382435 | GS1 | Ship Case | 2 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(800)348-2759
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 8 | Inch |