FDA UDI
In Commercial Distribution
🇺🇸 United States
Accu-Beam
DI: B17770430
·
Model: 7043
·
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Accu-Beam
- Primary DI
- B17770430
- Version / Model
- 7043
- Company Name
- TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
- Labeler DUNS
- 130213366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-06-15
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- aa98e091-9f5e-4ba9-a30e-139a6e1d78b1
Device Description
Leica Microscope M695, OHS, MS, M500 mount for micromanipulators.
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
- No
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 |
|---|---|---|---|---|
| 36184 | Laser adaptor | A connecting device, usually a small part, designed to join a device or component to a laser, or join devices being used with the laser, or to make any of these devices compatible so that they mate together (e.g., a laser contact probe from one manufacturer connect to the laser delivery arm of a laser from a different manufacturer). Included are optical couplers designed to connect a laser source to a fibreoptic laser delivery system. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B17770430 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K864378 | 000 |