FDA UDI
In Commercial Distribution
🇺🇸 United States
CROSSWAY
DI: 00889095998634
·
Model: 6177.1010S
·
GLOBUS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- CROSSWAY
- Primary DI
- 00889095998634
- Version / Model
- 6177.1010S
- Company Name
- GLOBUS MEDICAL, INC.
- Labeler DUNS
- 139105691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-07-12
- Public Version
- 3
- Public Version Date
- 2024-01-03
- Public Version Status
- Update
- Public Device Record Key
- 8c7ee8e5-2ad6-40fc-816f-4f470dfd768d
Device Description
Temporary Fixation Screw, 10mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 46650 | Spinal bone screw, bioabsorbable | A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a stabilization device (e.g., rod, plate) to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). The device is available in various types, including pedicle and transfacet, and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00889095998634 | GS1 |
Customer Contacts
- Phone
- +1(610)930-1800
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190598 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 10 | Millimeter |