FDA UDI
In Commercial Distribution
🇺🇸 United States
Alvarado® Knee Support
DI: 00889024370050
·
Model: 00-1320-015-10
·
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Alvarado® Knee Support
- Primary DI
- 00889024370050
- Version / Model
- 00-1320-015-10
- Catalog Number
- 00-1320-015-10
- 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
- 2020-09-21
- Public Version
- 1
- Public Version Date
- 2020-09-29
- Public Version Status
- New
- Public Device Record Key
- 88b7277f-e7b1-43ad-9a2e-233efbee3218
Device Description
Knee Holder Disposable Liner
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 |
|---|---|---|---|---|
| FWZ | Operating Room Accessories Table Tray | General, Plastic Surgery | 878.4950 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48139 | Orthopaedic knee/leg holder liner | A sterile pad/cover designed to be placed between a patient's leg and an orthopaedic knee/leg holder, cushioning the leg to reduce the risk of damage of the skin/muscles/nerves during an orthopaedic procedure (e.g., arthroscopy, arthroplasty). It is typically made of disposable plastic material (e.g., a foam) with an appropriate shape and size to fit the holder. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00889024378520 | GS1 | bOX | 10 | In Commercial Distribution | |
| Primary | 00889024370050 | GS1 |
Customer Contacts
- Phone
- 1(800)348-2759
- [email protected]