FDA UDI
In Commercial Distribution
🇺🇸 United States
STRYKER ADAPT
DI: 04546540696410
·
Model: 7700-600-000
·
Stryker Leibinger GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- STRYKER ADAPT
- Primary DI
- 04546540696410
- Version / Model
- 7700-600-000
- Catalog Number
- 7700-600-000
- 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
- 2016-08-24
- Public Version
- 5
- Public Version Date
- 2023-09-18
- Public Version Status
- Update
- Public Device Record Key
- 8e4470b4-1b44-44b7-b323-0e1325c76ab9
Device Description
Stryker ADAPT(R) PLATFORM
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
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PGW | Ear, Nose, and Throat Stereotaxic Instrument | Neurology | 882.4560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45199 | Multi-purpose stereotactic surgery system | An electrically-powered assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during a surgical procedure of more than one discipline [e.g., orthopaedic and ear/nose/throat (ENT)]. The system may include computerized functions to store diagnostic images used for image-guided surgery. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04546540696410 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 55 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 25 – 85 Percent (%) Relative Humidity
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Special Storage Condition, Specify
- Special Conditions
- 220-240 V~
- Type
- Special Storage Condition, Specify
- Special Conditions
- 50-60 HZ
- Type
- Special Storage Condition, Specify
- Special Conditions
- 100-120 V~