FDA UDI
In Commercial Distribution
🇺🇸 United States
Neurotips
DI: 00384705405019
·
Model: NT 0100
·
OWEN MUMFORD LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
100
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Basic Information
- Brand Name
- Neurotips
- Primary DI
- 00384705405019
- Version / Model
- NT 0100
- Company Name
- OWEN MUMFORD LIMITED
- Labeler DUNS
- 217266915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2019-10-03
- Public Version
- 1
- Public Version Date
- 2019-10-11
- Public Version Status
- New
- Public Device Record Key
- 597e5e88-68e7-4fb7-8426-8b3979fba0b8
Device Description
Sterile single use neuropathy screening pins
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 | 00384705405033 | GS1 | Case | 20 | In Commercial Distribution | |
| Package | 00384705405026 | GS1 | Sleeve | 5 | In Commercial Distribution | |
| Primary | 00384705405019 | GS1 | ||||
| Unit of Use | 00384705405002 | GS1 |
Customer Contacts
- Phone
- 770-977-2226
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius