Accu-Beam

Primary DI
B177950150700
Brand
Accu-Beam
Company
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Model
9501-50/70
Device description
Fiber Director 50/70, 2.0mm ID
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K910978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K910978000ACCU-BEAM LAPAROSCOPIC SYSTEMTti Medical1991-11-07GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B177950150700PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, reusableA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
130213366
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B1773122602B0Accu-Beam31226-02B2021-06-25
B17770590Accu-Beam70592026-07-28
B17731260532L0Accu-Beam31260-532L2025-07-23
B17731260532Z0Accu-Beam31260-532Z2025-07-23
B17731260455L0Accu-Beam31260-455L2025-07-21
B17731260455Z0Accu-Beam31260-455Z2025-07-21
B1773126002B0Accu-Beam31260-02B2021-06-25
B17704342043D0Accu-Beam04342043D2017-10-26
B17704342044C0Accu-Beam04342044C2017-10-26
B17770080Accu-Beam70082016-07-05
B1779450F0Accu-Surg9450F2026-04-21
B177950134700Accu-Beam9501-34/702022-02-23
B177700500180Accu-Beam700500182026-04-14
B17791852BDW0Accu-Beam9185-2B-DW2026-03-30
B17781860Accu-Beam81862020-05-19
B177301650T5320Accu-Beam301650T-5322021-11-19
B1778194101M0Accu-Beam8194101M2019-05-30
B1778194101M010Accu-Beam8194101M-012019-05-30
B1772000029800Accu-Beam2000029802019-01-25
B1772000039490Accu-Beam2000039492019-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432300MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432317MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432324MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432430MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432447MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776432454MillenniumAvalign Technologies, Inc.GEI2026-09-24
00190776431457MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432041MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432195MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776432201MillenniumAvalign Technologies, Inc.GEI2026-09-22
00190776431181MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431198MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431204MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431211MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431228MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431235MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431242MillenniumAvalign Technologies, Inc.GEI2026-09-21
00190776431259MillenniumAvalign Technologies, Inc.GEI2026-09-21
10840113236852BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236890BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113236937BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237040BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237064BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237101BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237118BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237132BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237415BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237439BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237507BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21
10840113237521BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-21