FDA UDI
In Commercial Distribution
🇺🇸 United States
Accu-Beam
DI: B17781941010
·
Model: 8194101
·
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accu-Beam
- Primary DI
- B17781941010
- Version / Model
- 8194101
- Company Name
- TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
- Labeler DUNS
- 130213366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-08-21
- Public Version
- 1
- Public Version Date
- 2018-09-21
- Public Version Status
- New
- Public Device Record Key
- 13d74dec-b3f2-4a17-beaf-cf9c1bccf826
Device Description
Canon APS-C Digital SLR camera adaptor. Mounts to Zeiss style beamsplitter.
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
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| KQM | Camera, Surgical And Accessories | General, Plastic Surgery | 878.4160 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32288 | Surgical camera holder | A device designed to hold or stabilize a video camera or endoscope while recording a surgical operative procedure. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B17781941010 | HIBCC |