FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 04546540364623
·
Model: 6001-200-010
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 04546540364623
- Version / Model
- 6001-200-010
- Catalog Number
- 6001-200-010
- 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
- 2016-08-24
- Public Version
- 5
- Public Version Date
- 2023-10-27
- Public Version Status
- Update
- Public Device Record Key
- d70d45bd-bb7d-4055-b103-204a2816b574
- Distribution End Date
- 2021-07-27
Device Description
SKULL POST
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| HAW | Neurological stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61405 | Surgical optical-tracking spatial marker cranial anchor | An invasive component of a surgical navigation and/or device tracking system (e.g., optical/electromagnetic device tracking system, computer-assisted neurosurgical ultrasound navigation system, surgical microscope equipped with a tracking camera) intended for intraoperative fixation to a patient’s skull to securely receive optical spatial markers/holders. It is made of metal and typically includes components for its fixation onto the skull (e.g., self-drilling screws) and for attachment of the spatial markers that allow rotation (e.g., connecting pins). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04546540364623 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 2.0 | Millimeter | |
| Device Size Text, specify | Diameter: 1.0 Millimeter |