FDA UDI
In Commercial Distribution
🇺🇸 United States
Accu-Beam
DI: B1773113WOL50
·
Model: 3113WOL5
·
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Accu-Beam
- Primary DI
- B1773113WOL50
- Version / Model
- 3113WOL5
- Company Name
- TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
- Labeler DUNS
- 130213366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-18
- Public Version
- 1
- Public Version Date
- 2019-01-18
- Public Version Status
- New
- Public Device Record Key
- 8d3b8afc-c6ac-48f6-8dcf-d2d1321a9fae
Device Description
Wolf Endo-Adaptor 5mm with direct coupler.
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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| HHR | Laser, Surgical, Gynecologic | Obstetrics/Gynecology | 884.4550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 18027 | Laparoscope laser coupler | A device used to connect a laser delivery system [e.g., the articulating arm of a carbon dioxide (CO2) laser] and a laparoscope; providing a coincidence between the aiming beam and the treatment beam at the target site. It typically consists of a lens housing including a set of lenses, a laparoscope adaptor, and a sleeve. It is attached to the laser delivery system at the proximal end and to the laparoscope at the distal end, and the sleeve is placed inside the working channel of the laparoscope to provide a path for the laser. The device is typically used for a procedure using a laser type which wavelength is not appropriate for fibreoptic cable transmission. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B1773113WOL50 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K870046 | 000 |