FDA UDI
In Commercial Distribution
🇺🇸 United States
Crossfire
DI: 07613327145205
·
Model: 0475000010
·
STRYKER CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Crossfire
- Primary DI
- 07613327145205
- Version / Model
- 0475000010
- Catalog Number
- 0475000010
- Company Name
- STRYKER CORPORATION
- Labeler DUNS
- 187502109
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 16c49036-94c2-43cf-b2e8-fcab08c43bd3
Device Description
Upgrade USB Dongle, V. R.1.6
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HRX | ARTHROSCOPE | Orthopedic | 888.1100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58895 | Arthroscopy information system application software | An application software program intended to be used as or in an appropriate information system to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within or between healthcare facilities, to support the administrative and clinical activities associated with orthopaedic arthroscopy procedures. It may be used to record arthroscopy treatment chains, to provide treatment effectiveness and quality reports, and to facilitate structured clinical research. It is typically installed into decentralized computers/networks. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07613327145205 | GS1 |
Customer Contacts
- Phone
- +1(866)624-4422
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K071859 | 000 |