FDA UDI
In Commercial Distribution
🇺🇸 United States
DUALX DUAL PORT OSTEOTOME STRAIGHT 4.0MM
DI: B707UOT1202410010
·
Model: UOT120241001
·
AMPLIFY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- DUALX DUAL PORT OSTEOTOME STRAIGHT 4.0MM
- Primary DI
- B707UOT1202410010
- Version / Model
- UOT120241001
- Company Name
- AMPLIFY SURGICAL, INC.
- Labeler DUNS
- 081021000
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-05
- Public Version
- 1
- Public Version Date
- 2026-02-13
- Public Version Status
- New
- Public Device Record Key
- a698c4d5-6f19-4fc0-9c4f-fb0f5615be58
Device Description
4.0MM
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
- Yes
- 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 |
|---|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12844 | Orthopaedic osteotome | A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B707UOT1202410010 | HIBCC |
Customer Contacts
- Phone
- 7652675439
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K181397 | 000 |