FDA UDI
In Commercial Distribution
🇺🇸 United States
DARCO® Monofilament Tester
DI: 00609271039803
·
Model: MFT
·
DARCO INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- DARCO® Monofilament Tester
- Primary DI
- 00609271039803
- Version / Model
- MFT
- Catalog Number
- MFT
- 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
- ce109805-9227-4fab-88e2-cb6202ef727e
Device Description
Universal
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 |
|---|---|---|---|---|
| GXB | ESTHESIOMETER | Neurology | 882.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61581 | Pressure algometer/aesthesiometer, mechanical | A manual, non-powered instrument designed to measure: 1) a patient's sensitivity to pain (pain threshold) by applying a painful, calibrated mechanical force to the skin; and 2) tactile sensibility by application of a thin filament(s) to the skin. It is typically a holder/pen which includes a strain gauge, a pressure algesimeter tip(s), and a thin filament(s) with a pre-set flexibility intended to apply a known pressure (point aesthesiometer). The device is typically used to evaluate the effects of pain after the use of anaesthesia/analgesics and/or during diagnosis or treatment of nerve injuries and neuropathies. This is a reusable device when the consumable products have been replenished. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10609271039800 | GS1 | Box | 24 | In Commercial Distribution | |
| Primary | 00609271039803 | GS1 | ||||
| Package | 20609271039807 | GS1 | Case | 288 | In Commercial Distribution |