FDA UDI
In Commercial Distribution
🇺🇸 United States
N/A
DI: 07613327499711
·
Model: 8900-200-200
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- N/A
- Primary DI
- 07613327499711
- Version / Model
- 8900-200-200
- Catalog Number
- 8900-200-200
- 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
- 2023-03-23
- Public Version
- 1
- Public Version Date
- 2023-03-31
- Public Version Status
- New
- Public Device Record Key
- 82a11bb5-4b2e-4fcf-9865-cd2803176e80
Device Description
EM Stylet
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
- MR Unsafe
- 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 |
|---|---|---|---|---|
| HAW | Neurological stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63570 | Intracranial catheter navigation transmitter stylet | A sterile, invasive, flexible wire with an electromagnetic (EM) coil transmitter at the distal end designed to be inserted into an intracranial catheter to help guide the surgical insertion of the catheter through the skull for placement in the brain. It is proximally connected to a line-powered EM neurosurgical navigation system which tracks and displays the position of the stylet for precise navigation during the procedure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 37613327499712 | GS1 | pack | 5 | In Commercial Distribution | |
| Primary | 07613327499711 | GS1 |
Storage Conditions
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Fragile, Handle with Care
- Type
- Special Storage Condition, Specify
- Special Conditions
- Transport humidity, 90, 10, Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- Transport temperature, 50, -10, Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 35 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Special Storage Condition, Specify
- Special Conditions
- Transport atmospheric pressure, 106, 70, Kilo Pascal
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep Dry