FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 07613327298062
·
Model: 5140-534-627
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 07613327298062
- Version / Model
- 5140-534-627
- Catalog Number
- 5140-534-627
- Company Name
- Stryker Leibinger GmbH & Co. KG
- Labeler DUNS
- 316153956
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-12-23
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 6b1cefd9-59ac-4f02-8837-a4b431e1967c
Device Description
Paired Subdermal Electrode VT, 18x2.5mm
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 |
|---|---|---|---|---|
| 47714 | Subdermal needle electrode | A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613327298063 | GS1 | pack | 10 | In Commercial Distribution | |
| Primary | 07613327298062 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Offset: 2.5 Millimeter | ||
| Length | 18.0 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- TRANSPORT: 10-90%, -20+50¿C