Medipin
Basic Information
- Brand Name
- Medipin
- Primary DI
- 05060631140013
- Version / Model
- The Diabetic Toes Test by Medipin
- Catalog Number
- MP-12
- Company Name
- MEDIPIN LIMITED
- Labeler DUNS
- 737328851
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2021-03-25
- Public Version
- 2
- Public Version Date
- 2023-06-26
- Public Version Status
- Update
- Public Device Record Key
- f6bc8a07-b69f-4b05-b16c-a2660f5e863f
Device Description
A carton of 12 Single-Use Protected Neurological Pins intended to allow patients with diabetes to test themselves safely at home monthly for early signs of diabetic neuropathy according to American Diabetes Association guidelines - A disposable precision esthesiometer for testing cutaneous pinprick sensation designed to optimise the patient's perception of sharpness without piercing delicate skin for use in the clinical or non-clinical setting. GMDN Definition: A hand-held manual pin-like device with a sharp distal end intended to be used to test for the presence of pain (pin prick) sensation in the skin. A healthcare professional uses the device to touch the skin of a patient who provides a response based on the sensation experienced; the device may have a safety feature to prevent unintentional injury. This is a single-use device.
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
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GXB | Esthesiometer | Neurology | 882.1500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64709 | Neurological pain-testing pin | A hand-held manual pin-like device with a sharp distal end intended to be used to test for the presence of pain (pin prick) sensation in the skin. A healthcare professional uses the device to touch the skin of a patient who provides a response based on the sensation experienced; the device may have a safety feature to prevent unintentional injury. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060631140013 | GS1 | ||||
| Unit of Use | 05060631140020 | GS1 |
Customer Contacts
- Phone
- +447801986515
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 80 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius