FDA UDI
In Commercial Distribution
🇺🇸 United States
Boundary
DI: 00814008025541
·
Model: BUT-1000T-AWL
·
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Boundary
- Primary DI
- 00814008025541
- Version / Model
- BUT-1000T-AWL
- Company Name
- NVISION BIOMEDICAL TECHNOLOGIES, INC.
- Labeler DUNS
- 047486041
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-07-11
- Public Version
- 5
- Public Version Date
- 2024-11-13
- Public Version Status
- Update
- Public Device Record Key
- 1d1b1a9d-4180-4702-be16-e573d316f7b1
Device Description
Instrument, Lumbar Buttress Plate Awl. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Orthopedic | 888.3060 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15275 | Bone awl, reusable | A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00814008025541 | GS1 |
Customer Contacts
- Phone
- 210-545-3713
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K173091 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time