FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 07613327282221
·
Model: 5140-522-603
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 07613327282221
- Version / Model
- 5140-522-603
- Catalog Number
- 5140-522-603
- Company Name
- Stryker Leibinger GmbH & Co. KG
- Labeler DUNS
- 316153956
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-22
- Public Version
- 3
- Public Version Date
- 2023-08-01
- Public Version Status
- Update
- Public Device Record Key
- 9b2581ef-af78-4efd-bbc3-e3b4186bd31c
- Distribution End Date
- 2020-12-31
Device Description
Bipolar Probe 45mm, angled 30 degree
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE | Neurology | 882.1870 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61089 | Nerve-locating system probe, single-use | A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613327282222 | GS1 | pack | 10 | Not in Commercial Distribution | 2020-12-31 |
| Primary | 07613327282221 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Angle | 30.0 | degree | |
| Length | 45.0 | Millimeter |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 35 Degrees Celsius