FDA UDI
In Commercial Distribution
🇺🇸 United States
MECRON Knee Flexion L:500mm, OS:540mm, US:330mm
DI: 00609271950368
·
Model: OH500301
·
DARCO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- MECRON Knee Flexion L:500mm, OS:540mm, US:330mm
- Primary DI
- 00609271950368
- Version / Model
- OH500301
- Catalog Number
- OH500301
- Company Name
- DARCO INTERNATIONAL, INC.
- Labeler DUNS
- 184231298
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-08
- Public Version
- 1
- Public Version Date
- 2023-02-16
- Public Version Status
- New
- Public Device Record Key
- 8a58c42c-5d06-4bad-a9ed-600531da646b
Device Description
L Blue 20° / 50 cm
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
- No
- 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
- 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 |
|---|---|---|---|---|
| ITQ | JOINT, KNEE, EXTERNAL BRACE | Physical Medicine | 890.3475 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12099 | Knee immobilizer | A rigid support used to temporarily render the knee immovable, either preoperatively or following injury or arthroscopy. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10609271950365 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00609271950368 | GS1 |