FDA UDI
In Commercial Distribution
🇺🇸 United States
MotoBAND CP
DI: 00850038154240
·
Model: 7100-UB5N
·
CROSSROADS EXTREMITY SYSTEMS
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MotoBAND CP
- Primary DI
- 00850038154240
- Version / Model
- 7100-UB5N
- Catalog Number
- 7100-UB5N
- Company Name
- CROSSROADS EXTREMITY SYSTEMS
- Labeler DUNS
- 058864308
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-21
- Public Version
- 7
- Public Version Date
- 2026-03-04
- Public Version Status
- Update
- Public Device Record Key
- 1ac839f2-769b-44ef-a485-18044d9b8780
Device Description
The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws.
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
- 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 |
|---|---|---|---|---|
| HRS | Plate, Fixation, Bone | Orthopedic | 888.3030 | 2 |
| HWC | Screw, Fixation, Bone | Orthopedic | 888.3040 | 2 |
| JDR | Staple, Fixation, Bone | Orthopedic | 888.3030 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46647 | Orthopaedic fixation plate, non-bioabsorbable | A non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850038154240 | GS1 |