FDA UDI
In Commercial Distribution
🇺🇸 United States
Provecta HD 16" Center to Center Wall Mounting Plate
DI: D678A63410
·
Model: A6341
·
AIR TECHNIQUES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Provecta HD 16" Center to Center Wall Mounting Plate
- Primary DI
- D678A63410
- Version / Model
- A6341
- Company Name
- AIR TECHNIQUES, INC.
- Labeler DUNS
- 043835081
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-11
- Public Version
- 1
- Public Version Date
- 2023-07-19
- Public Version Status
- New
- Public Device Record Key
- 37058da6-008a-4082-8148-6d94b0f0d210
Device Description
The Provecta HD 16" Center to Center Wall Mounting Plate is used to secure the Provecta HD X-ray unit onto a facility wall via two wooden 2"x4" wall studs located 16 inches on center apart.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYB | Tube Mount, X-Ray, Diagnostic | Radiology | 892.1770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65120 | Custom-made medical device mount | A structure intended to be permanently-fixed to the ceiling and/or wall to support/stow a medical device(s) [e.g., light, monitor, surgical instruments] or stow/provide medical supplies. It is designed with specific characteristics as requested by a healthcare professional to meet the requirements of a specific facility. It may incorporate a pole, rack, shelves, electricity supply sockets, gas outlets, and/or enable dynamic positioning (e.g., with dynamic arms, sliding bracket); the device(s) to be mounted is not included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | D678A63301 | HIBCC | Box | 1 | In Commercial Distribution | |
| Primary | D678A63410 | HIBCC |
Customer Contacts
- Phone
- +1 (516) 214-5512
- [email protected]