FDA.report

Accu-Beam

Primary DI
B1778007I0
Brand
Accu-Beam
Company
TRANSAMERICAN TECHNOLOGIES INTERNATIONAL
Model
8007I
Device description
17mm focal length Endoscopic Coupler. Insulated.
Published
2018-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FWLCamera, Cine, Endoscopic, Without Audio

Product Code Classifications

CodeDeviceSpecialtyClass
FWLCamera, Cine, Endoscopic, Without AudioGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B1778007I0PrimaryHIBCC0

GMDN Terms

TermDefinition
Endoscope camera adaptorA device designed to connect a camera (moving- or still-image) to a non-video endoscope (rigid or flexible), especially when the devices are from different manufacturers. This is a reusable device.

Sterilization Methods

Method
Hydrogen Peroxide

Regulatory Flags

DUNS number
130213366
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

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B1779185OTO0Accu-Beam9185-OTO2025-08-11
B17731260532L0Accu-Beam31260-532L2025-07-23
B17731260532Z0Accu-Beam31260-532Z2025-07-23
B17731260455L0Accu-Beam31260-455L2025-07-21
B17731260455Z0Accu-Beam31260-455Z2025-07-21
B1779115130Accu-Beam9115-132025-07-21
B1771104R0Accu-Beam1104R2025-02-25
B17761090Accu-Beam61092024-11-11
B1771056521SM0Accu-Beam1056521SM2024-11-07
B177AC1069640013Accu-BeamAC-1069640-12024-09-26
B177062537602T0Accu-Beam0625-376-02T2024-08-06
B17770560Accu-Beam70562024-02-20
B177A55014900TTI0Accu-BeamA55014900-TTI2024-01-04
B17700100852P0Accu-Beam0010-0852P2023-11-20
B17700100853P0Accu-Beam0010-0853P2023-11-20
B17700100991T0Accu-Beam0010-0991T2023-11-20
B17710597020Accu-Beam10597022023-01-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08908025548083UnivLabs UNIVLABS TECHNOLOGIES PRIVATE LIMITEDFWL2025-07-01
00840319757963Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757970Hayden MedicalHayden Medical, Inc.FWL2025-04-11
00840319757321Hayden MedicalHayden Medical, Inc.FWL2024-06-27
08800033200048ITS Model-L6KInTheSmart Co., Ltd.FWL2022-11-11
00078301211227Health SupportCarolon CompanyFWL2022-10-18
00851289007224Firefly Firefly GlobalFWL2022-09-20
00860006918705ProsidioProsidio LLCFWL2021-06-06
00857326005567FocESSENTELLUS MEDICAL, INC.FWL2020-09-18
00863333000327DUROSCOPEFMD, LLCFWL2019-02-09
00863333000334DUROSCOPEFMD, LLCFWL2019-02-09
00863333000358DUROSCOPEFMD, LLCFWL2019-02-09
86333300030188DUROSCOPEFMD, LLCFWL2019-02-09
86333300030218DUROSCOPEFMD, LLCFWL2019-02-09
86333300030232DUROSCOPEFMD, LLCFWL2019-02-09
B1778020RF0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-10-18
B1778008I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778009I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778013I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778019I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B1778020I0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780500Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780510Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
B17780520Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALFWL2018-08-29
00851289007040RedfinFirefly GlobalFWL2018-08-14
00851289007057FireflyFirefly GlobalFWL2018-08-14
B351MV80000mytaMedMytamed, Inc.FWL2018-02-16
B351MV80010mytaMedMytamed, Inc.FWL2018-02-16
B351MV80020mytaMedMytamed, Inc.FWL2018-02-16
B351MV80030mytaMedMytamed, Inc.FWL2018-02-16