FDA UDI
In Commercial Distribution
🇺🇸 United States
J&J Instruments
DI: 00817524029956
·
Model: 18-6040
·
J & J INSTRUMENTS INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- J&J Instruments
- Primary DI
- 00817524029956
- Version / Model
- 18-6040
- Catalog Number
- 18-6040
- Company Name
- J & J INSTRUMENTS INC
- Labeler DUNS
- 783328149
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-08
- Public Version
- 1
- Public Version Date
- 2023-06-16
- Public Version Status
- New
- Public Device Record Key
- 18db0d16-ddda-49cd-a575-2393774f6d07
Device Description
WARTENBERG PINWHEEL 6"
Device Characteristics
- Single Use
- No
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GWY | Pinwheel | Neurology | 882.1750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47163 | Pinwheel aesthesiometer | A manual stimulator designed to determine tactile sensibility by testing a patient's discrimination of diameter in rods mounted on a disc. It typically consists of a disc, with protruding rods that differ in diameter, mounted on a rotary pin; the disc is manually rotated on the patient's skin by moving an integral handle at the proximal end. The rods may be sharply pointed for testing pain sensation. The device is typically used during physical examinations for detecting peripheral neuropathy and/or in diabetes mellitus or leprosy diagnostics. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00817524029956 | GS1 |