FDA UDI
In Commercial Distribution
🇺🇸 United States
MASADA
DI: 00840085201691
·
Model: 5.750-N-VE
·
Astura Medical
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MASADA
- Primary DI
- 00840085201691
- Version / Model
- 5.750-N-VE
- Catalog Number
- 5.750-N-VE
- Company Name
- Astura Medical
- Labeler DUNS
- 073029645
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-16
- Public Version
- 3
- Public Version Date
- 2025-12-10
- Public Version Status
- Update
- Public Device Record Key
- 7ae174a1-989e-409d-bc1c-59701738c585
Device Description
BAITELLA UNIVERSAL RADIAL CLAMP
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
- 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 |
|---|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Orthopedic | 888.3080 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Orthopedic | 888.3080 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35595 | Bone clamp traction bar | A manual surgical device designed to bridge two opposing bone clamps being used as a pair, one on either side of a fracture (the proximal and distal segment of a fractured bone) that is being approximated during orthopaedic surgery. It is attached to the stem of each of the bone clamps and using its screw mechanism, the fracture is drawn together by the surgeon. It is typically made of high-grade stainless steel and is designed for this function only. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840085201691 | GS1 |
Customer Contacts
- Phone
- 7608148047
- [email protected]