FDA UDI
In Commercial Distribution
🇺🇸 United States
De Mayo Ankle Distractor™
DI: 00696588005348
·
Model: 1109-XS KIT DEMO
·
Innovative Medical Products, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- De Mayo Ankle Distractor™
- Primary DI
- 00696588005348
- Version / Model
- 1109-XS KIT DEMO
- Catalog Number
- 1109-XS KIT DEMO
- Company Name
- Innovative Medical Products, Inc
- Labeler DUNS
- 147363154
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-08
- Public Version
- 1
- Public Version Date
- 2019-11-18
- Public Version Status
- New
- Public Device Record Key
- c4e96043-1c85-4cea-8b42-a38936625c30
Device Description
Demo De Mayo Ankle Distractor™ Sterilization Cases (1 each of 1109-XS and 1109-S)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 62787 | Orthopaedic surgical distractor, external | A hand-operated surgical instrument designed to noninvasively distract (force apart) a joint to facilitate an orthopaedic surgical procedure (e.g., hip arthroscopy). It is a mechanical tool with a manual trigger, for distraction and release, intended to be stabilized against a fixation point adjacent to the target joint (e.g., between the knee and the thigh for knee distraction, or between the joint and a patient positioner attached to the operating table). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00696588005348 | GS1 |