FDA UDI
In Commercial Distribution
🇺🇸 United States
De Mayo Knee Positioner®
DI: 00696588002811
·
Model: 803-NSP-10
·
Innovative Medical Products, Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- De Mayo Knee Positioner®
- Primary DI
- 00696588002811
- Version / Model
- 803-NSP-10
- Catalog Number
- 803-NSP-10
- Company Name
- Innovative Medical Products, Inc
- Labeler DUNS
- 147363154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-09-23
- Public Version
- 2
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- 4d57bef3-abf5-4a53-889d-66be37648914
Device Description
Non-sterile Patient Protective Pad for De Mayo Knee Positioner® (10/case)
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
- No
- 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 |
|---|---|---|---|---|
| 62619 | Surgical linen/cushion set | A collection of devices intended to be fitted to equipment used to support a patient during surgery (e.g., operating table) to provide a hygienic barrier and positioning/support capabilities. It typically includes operating table sheets, covers, pillows/cushions, foam pads, and equipment drapes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00696588002811 | GS1 | ||||
| Unit of Use | 00696588002804 | GS1 |