FDA UDI
In Commercial Distribution
🇺🇸 United States
MECRON Knee Flexion L:500mm, OS:540mm, US:330mm
DI: 00609271950375
·
Model: OH500302
·
Darco (Europe) GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MECRON Knee Flexion L:500mm, OS:540mm, US:330mm
- Primary DI
- 00609271950375
- Version / Model
- OH500302
- Catalog Number
- OH500302
- Company Name
- Darco (Europe) GmbH
- Labeler DUNS
- 343551081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-02-08
- Public Version
- 4
- Public Version Date
- 2025-07-11
- Public Version Status
- Update
- Public Device Record Key
- e2377da5-1fe3-4f13-8458-7869c69a8041
Device Description
L Vinyl 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 |
|---|---|---|---|---|
| 41065 | Knee support orthosis | A stand-alone prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to support, align, prevent, or correct deformities/injuries or to improve function of the knee; it may incorporate hinges for improved support. It is not a component of a larger device assembly. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10609271950372 | GS1 | Box | 12 | In Commercial Distribution | |
| Primary | 00609271950375 | GS1 |