Accu-Beam

GUDID B177AC20596200

FiberLase GYN LAP-P Handpiece. Stainless Steel.

TRANSAMERICAN TECHNOLOGIES INTERNATIONAL

General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable
Primary Device IDB177AC20596200
NIH Device Record Keyd8e5d4c2-a6b6-415a-adc5-cb73753a7d53
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccu-Beam
Version Model NumberAC-2059620
Company DUNS130213366
Company NameTRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB177AC20596200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


[B177AC20596200]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2016-06-20

On-Brand Devices [Accu-Beam]

B177TTIHDR0Single chip video camera with recorder. 1080p 60hz, HDMI output.
B177TTIHD0Single chip video camera without recorder. 1080p 60hz, HDMI output.
B177ST656180LED Pen Light with Clip and removable diffuser.
B177SA10597510Re-usable fiberoptic handpiece for lasers. Straight/Rigid - 24cm, 14ga, ID 1.5mm.
B177LEDTCCW0Topcon LED Illumination upgrade. Continuous wave only.
B177LEDHSFL0Haag Streit LED Illumination upgrade. Continuous wave & Synchro Flash (for use with Canon DSLR c
B177LEDHSCW0Haag Streit LED Illumination upgrade. Continuous wave only.
B177HS0512V0Haag Streit BQ/BX single port beamsplitter. Vertical mount.
B177FS1010Footswitch for Canon SLR camera.
B177CADPTR05mm spacer ring, converts C-mount into CS-mount.
B177AC330MMR0Re-usable fiberoptic handpiece for lasers. Straight/Rigid - 33cm, 14ga, ID 1.5mm, spatula tip.
B177AC20596300FiberLase GYN LAP-S Handpiece. Stainless Steel.
B177AC20596200FiberLase GYN LAP-P Handpiece. Stainless Steel.
B177AC10596401Fiberlase GYN LAP Brush Kit. Pack of 5.
B177AC10596300FiberLase GYN LAP-S Handpiece. Aluminum.
B177AC10596200FiberLase GYN LAP-R Handpiece. Aluminum.
B1779851022 Gauge x 36cm Needle.
B1779850016 Gauge x 36cm Needle.
B17795397010mm x 33cm Cannula with Holes.
B1779458L010mm x 33cm Pool Suction Cannula.
B1779457L05mm x 44cm cannula with holes.
B1779455L0010mm x 33cm Outer Cannula without Holes.
B1779455L010mm x 33cm Outer Cannula with Holes.
B1779453L205mm x 33cm Outer Cannula with Holes WT.03.
B1779453L005mm x 33cm Outer Cannula without Holes.
B1779453L05mm x 33cm Outer Cannula with Holes.
B1779452L05mm x 29cm Hydro-Dissection Cannula.
B1779451L005mm x 27.4cm Outer Cannula without Holes.
B1779451L05mm x 27.4cm Cannula with Holes.
B1779450L0Dual Trumpet Valve Handle with Parallel valve.
B1779440F02705mm x 33cm Non-conductive Outer Cannula.
B1779440F0250Sealing End Cap, Non-conductive.
B1779440F0Non-conductive Dual Trumpet Valve Handle.
B17793620Bipolar Retractable/Rotatable Electrode Ball.
B17793610Bipolar Retractable/Rotatable Electrode Needle.
B17793600Bipolar Retractable/Rotatable Electrode L-hook.
B17793580Monopolar Cable for Retractable/Rotatable Electrodes.
B1779354010Monopolar Retractable/Rotatable Ball Electrode (2mm tip).
B1779353010Monopolar Retractable/Rotatable Electrode Needle.
B1779352010Monopolar Retractable/Rotatable Electrode Right Angle.
B1779351010Monopolar Retractable/Rotatable Electrode Hook.
B1779350010Monopolar Retractable/Rotatable Electrode Spatula.
B17793312Tuohy-Borsst Adapter for 1,000-2,300u fiber (package of 10).
B17793302Tuohy-Borsst Adapter for 600-1,000u fiber (package of 10).
B1779315L0Trumpet Valve Piston.
B1779314L0Trumpet Valve Upper Cap with Spring.
B1779313L0Trumpet Valve Lower Cap.
B1779310100Cleaning Brush, 10mm.
B17793100Cleaning Brush, 5mm.
B17793070Adapter to connect Davol, Karl Storz, and American Hydro Surgical Cannulas to Stainless Steel AC

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