FDA UDI
In Commercial Distribution
🇺🇸 United States
Accu-Beam
DI: B17793312
·
Model: 9331
·
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
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Basic Information
- Brand Name
- Accu-Beam
- Primary DI
- B17793312
- Version / Model
- 9331
- Company Name
- TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
- Labeler DUNS
- 130213366
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2016-07-13
- Public Version
- 5
- Public Version Date
- 2019-08-21
- Public Version Status
- Update
- Public Device Record Key
- 168757ad-b682-4731-aeee-e723361ba8c5
Device Description
Tuohy-Borsst Adapter for 1,000-2,300u fiber (package of 10).
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 |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57822 | Surgical irrigation/aspiration handpiece, reusable | A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B17793312 | HIBCC | ||||
| Unit of Use | B17793310 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K910978 | 000 |