| Primary Device ID | B17780510 |
| NIH Device Record Key | fb85cb16-1857-4e14-8328-ed74e01f2179 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Accu-Beam |
| Version Model Number | 8051 |
| Company DUNS | 130213366 |
| Company Name | TRANSAMERICAN TECHNOLOGIES INTERNATIONAL |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B17780510 [Primary] |
| FWL | Camera, Cine, Endoscopic, Without Audio |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
[B17780510]
Hydrogen Peroxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-10-01 |
| Device Publish Date | 2018-08-29 |
| B177TTIHDR0 | Single chip video camera with recorder. 1080p 60hz, HDMI output. |
| B177TTIHD0 | Single chip video camera without recorder. 1080p 60hz, HDMI output. |
| B177ST656180 | LED Pen Light with Clip and removable diffuser. |
| B177SA10597510 | Re-usable fiberoptic handpiece for lasers. Straight/Rigid - 24cm, 14ga, ID 1.5mm. |
| B177LEDTCCW0 | Topcon LED Illumination upgrade. Continuous wave only. |
| B177LEDHSFL0 | Haag Streit LED Illumination upgrade. Continuous wave & Synchro Flash (for use with Canon DSLR c |
| B177LEDHSCW0 | Haag Streit LED Illumination upgrade. Continuous wave only. |
| B177HS0512V0 | Haag Streit BQ/BX single port beamsplitter. Vertical mount. |
| B177FS1010 | Footswitch for Canon SLR camera. |
| B177CADPTR0 | 5mm spacer ring, converts C-mount into CS-mount. |
| B177AC330MMR0 | Re-usable fiberoptic handpiece for lasers. Straight/Rigid - 33cm, 14ga, ID 1.5mm, spatula tip. |
| B177AC20596300 | FiberLase GYN LAP-S Handpiece. Stainless Steel. |
| B177AC20596200 | FiberLase GYN LAP-P Handpiece. Stainless Steel. |
| B177AC10596401 | Fiberlase GYN LAP Brush Kit. Pack of 5. |
| B177AC10596300 | FiberLase GYN LAP-S Handpiece. Aluminum. |
| B177AC10596200 | FiberLase GYN LAP-R Handpiece. Aluminum. |
| B17798510 | 22 Gauge x 36cm Needle. |
| B17798500 | 16 Gauge x 36cm Needle. |
| B177953970 | 10mm x 33cm Cannula with Holes. |
| B1779458L0 | 10mm x 33cm Pool Suction Cannula. |
| B1779457L0 | 5mm x 44cm cannula with holes. |
| B1779455L00 | 10mm x 33cm Outer Cannula without Holes. |
| B1779455L0 | 10mm x 33cm Outer Cannula with Holes. |
| B1779453L20 | 5mm x 33cm Outer Cannula with Holes WT.03. |
| B1779453L00 | 5mm x 33cm Outer Cannula without Holes. |
| B1779453L0 | 5mm x 33cm Outer Cannula with Holes. |
| B1779452L0 | 5mm x 29cm Hydro-Dissection Cannula. |
| B1779451L00 | 5mm x 27.4cm Outer Cannula without Holes. |
| B1779451L0 | 5mm x 27.4cm Cannula with Holes. |
| B1779450L0 | Dual Trumpet Valve Handle with Parallel valve. |
| B1779440F0270 | 5mm x 33cm Non-conductive Outer Cannula. |
| B1779440F0250 | Sealing End Cap, Non-conductive. |
| B1779440F0 | Non-conductive Dual Trumpet Valve Handle. |
| B17793620 | Bipolar Retractable/Rotatable Electrode Ball. |
| B17793610 | Bipolar Retractable/Rotatable Electrode Needle. |
| B17793600 | Bipolar Retractable/Rotatable Electrode L-hook. |
| B17793580 | Monopolar Cable for Retractable/Rotatable Electrodes. |
| B1779354010 | Monopolar Retractable/Rotatable Ball Electrode (2mm tip). |
| B1779353010 | Monopolar Retractable/Rotatable Electrode Needle. |
| B1779352010 | Monopolar Retractable/Rotatable Electrode Right Angle. |
| B1779351010 | Monopolar Retractable/Rotatable Electrode Hook. |
| B1779350010 | Monopolar Retractable/Rotatable Electrode Spatula. |
| B17793312 | Tuohy-Borsst Adapter for 1,000-2,300u fiber (package of 10). |
| B17793302 | Tuohy-Borsst Adapter for 600-1,000u fiber (package of 10). |
| B1779315L0 | Trumpet Valve Piston. |
| B1779314L0 | Trumpet Valve Upper Cap with Spring. |
| B1779313L0 | Trumpet Valve Lower Cap. |
| B1779310100 | Cleaning Brush, 10mm. |
| B17793100 | Cleaning Brush, 5mm. |
| B17793070 | Adapter to connect Davol, Karl Storz, and American Hydro Surgical Cannulas to Stainless Steel AC |