Accu-Beam

GUDID B17710597910

Re-usable fiberoptic handpiece for CO2 lasers. 60mm, 15 degree bend, spatula tip, blue.

TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

General/multiple surgical laser system beam guide, reusable

• Primary Device ID: B17710597910
• NIH Device Record Key: 4278cbf9-6deb-4972-a595-d27758bb7227
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accu-Beam
• Version Model Number: 1059791
• Company DUNS: 130213366
• Company Name: TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B17710597910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952006

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

[B17710597910]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-01
• Device Publish Date: 2020-03-13

On-Brand Devices [Accu-Beam]

• 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