FDA UDI
In Commercial Distribution
🇺🇸 United States
A.T.S.®
DI: 00889024376786
·
Model: 60-4009-101-00
·
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- A.T.S.®
- Primary DI
- 00889024376786
- Version / Model
- 60-4009-101-00
- Catalog Number
- 60-4009-101-00
- 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
- 2021-11-01
- Public Version
- 1
- Public Version Date
- 2021-11-09
- Public Version Status
- New
- Public Device Record Key
- ec174e21-309c-450e-a9e9-75fc766f46f7
Device Description
Single Hose with CPC Connectors
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
- MR Conditional
- 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 |
|---|---|---|---|---|
| 14074 | Surgical pneumatic tourniquet system | A device assembly intended to occlude the blood flow and to obtain a bloodless field during limb surgery or amputation. It typically consists of a pneumatic tourniquet cuff, a source of gas pressure used to inflate the cuff, and a control unit, i.e., a pressure indicator and regulator. By using a double cuff and a manual switching or automatic valve, the pressure point is regularly changed to avoid tissue damage or necrosis. The device will also typically include a timer or elapsed-time meter. It may also be used in combination with intravenous local anaesthesia to limit the area affected by the anaesthesia. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00889024380455 | GS1 | Shelf Carton | 10 | In Commercial Distribution | |
| Primary | 00889024376786 | GS1 | ||||
| Package | 00889024382336 | GS1 | Ship Case | 2 | In Commercial Distribution |