FDA.reportPublic FDA data

USA Series

Primary DI
00821925008915
Brand
USA Series
Company
Gyrus ACMI, LLC
Model
G27L-12A
Device description
USA Series Long Autoclavable Operative Telescope 12 Degrees, 2.7 mm Diameter
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FHOpneumoperitoneum needle
HEWCuldoscope (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHOPneumoperitoneum NeedleGastroenterology, Urology2
HEWCuldoscope (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K980972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K980972000RIGID CULDOSCOPE AND ACCESSORIESCircon Corp.1998-06-12HEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925008915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008915008219250089158219250089150821925008915

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscope telescopeAn optical device designed to provide the illumination and image transmission capabilities of a rigid endoscope. It typically includes a set of lenses (e.g., thin and rod-shaped lenses) and/or a fibreoptic bunch, and is introduced though the sheath of the endoscope (e.g., a rigid cystoscope or resectoscope). The endoscopic telescope is connected proximally to a light source, and the returning image is directly observed or scanned with a video camera. Dedicated types are available for direct, lateral, and oblique views. It is used for examination of body cavities following natural tracts (e.g., urinary, gastrointestinal) or surgical cavities (e.g., laparoscopic). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925033900DIEGO701390022024-07-25
00821925033917DIEGO701390062024-07-24
00821925034419DIEGO701390332024-07-23
00821925034730Gyrus ACMI703531002017-05-11
00821925034754Gyrus ACMI703531122017-05-11
00821925035935OLYMPUS37402016-10-03
00821925001428GYRUS ACMICW-USLPC2016-10-13
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceAPPLIED MEDICAL RESOURCES CORPORATIONHEW2026-04-22
06937845500607GTKGuangzhou T.K Medical Instrument Co.,Ltd.FHO2024-05-23
06937845500614GTKGuangzhou T.K Medical Instrument Co.,Ltd.FHO2024-05-23
00850059707005AccuMedxAccumedx, LLCFHO2024-01-23
00850059707012AccuMedxAccumedx, LLCFHO2024-01-23
00810143450545MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpFHO2023-07-31
00810143450750MD EndoGuidance Laparoscopic InsufflatorMedical Disposables CorpFHO2023-07-31
19349967004996ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
19349967005009ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
29349967004993ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
29349967005006ColpotomizOR Tube SystemTHE O R COMPANY PTY LTDHEW2023-04-04
10607915145313GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145320GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915145337GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
10607915146693GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-03-17
00607915145613GelPOINT V-Path APPLIED MEDICAL RESOURCES CORPORATIONHEW2023-02-17
00888937015737Koh CupCoopersurgical, Inc.HEW2022-12-01
00888937015744Koh CupCoopersurgical, Inc.HEW2022-12-01
00888937015751Koh CupCoopersurgical, Inc.HEW2022-12-01
20888937015700Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
20888937015717Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
20888937015724Ultem Koh Cup Coopersurgical, Inc.HEW2022-12-01
00888937015065RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015072RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015089RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015096RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015102RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015119RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015126RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10
00888937015133RUMI II Koh-EfficientCoopersurgical, Inc.HEW2022-11-10