FDA UDI
In Commercial Distribution
🇺🇸 United States
UKnee Suspended Knee Positioner
DI: 00696588007793
·
Model: 824-P
·
Innovative Medical Products, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
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Basic Information
- Brand Name
- UKnee Suspended Knee Positioner
- Primary DI
- 00696588007793
- Version / Model
- 824-P
- Catalog Number
- 824-P
- Company Name
- Innovative Medical Products, Inc
- Labeler DUNS
- 147363154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2024-11-14
- Public Version
- 2
- Public Version Date
- 2024-12-16
- Public Version Status
- Update
- Public Device Record Key
- 618ce9ef-6e04-452b-96c9-758926a602ec
Device Description
Sterile Pad Set for UKnee-SKP™ Unicompartmental Suspended Knee Positioner
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMP | Protector, Skin Pressure | General Hospital | 880.6450 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00696588007786 | GS1 | ||||
| Primary | 00696588007793 | GS1 |