FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925038110
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
AE-1
Device description
Endoscopic Instrument Lubricant (3/PK)
Published
2016-10-12
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
CCWLARYNGOSCOPE, RIGID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K883819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K883819000BULLARD INTUBATING LARYNGOSCOPE LAR-A & LAR-PCircon Acmi1988-10-17CCW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925008823PackageGS13In Commercial Distribution
00821925038110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925008823008219250088238219250088230821925008823
00821925038110008219250381108219250381100821925038110

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument maintenance lubricantA non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13
00821925037090Gyrus ACMI708907332018-09-13
00821925037106SlimLine708907342018-09-13
00821925037113Gyrus ACMI708907352018-09-13
00821925037120Gyrus ACMI708907372018-09-13
00821925037137Gyrus ACMI708907382018-09-13
00821925037144Gyrus ACMI708907392018-09-13
00821925037151Gyrus ACMI708907402018-09-13
00821925037168Gyrus ACMI708907412018-09-13
00821925037175Gyrus ACMI708907422018-09-13
00821925037182Gyrus ACMI708907432018-09-13
00821925037199Gyrus ACMI708907502018-09-13
00821925037205Gyrus ACMI708907512018-09-13
00821925037212Gyrus ACMI708907522018-09-13
00821925037229Gyrus ACMI708907532018-09-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251346Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251353Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251360Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251377Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251384Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251391Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251414Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251421Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251445Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251452Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251469Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251476Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251483Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251490Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055251506Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257744Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257768Surgical DesignSurgical Design, Inc.CCW2026-06-09
00810055257782Surgical DesignSurgical Design, Inc.CCW2026-06-09
00879123009340GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
00879123009357GlideScope®Verathon Medical (Canada) ULCCCW2026-05-29
08436031030112AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030211AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030310AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030419AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030518AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031030617AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033908AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031033922AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035018AirtraqPRODOL MEDITEC, SACCW2023-08-01