FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925007321
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
75U
Device description
Universal Stopcock Adapter Luer Lock
Published
2018-09-13
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
00821925007321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925007321008219250073218219250073210821925007321

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic biopsy valve, single-useA device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include a water input valve for simultaneous irrigation/biopsy. This is a single-use device.

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
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719874957506Create BiotechCREATE BIOTECH CO., LTD.CCW2026-07-21
10884521859999McGRATH MAC+Covidien LPCCW2026-07-03
04053755200122visionPRO Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-24
04053755213092MEDUVISION Set MacHeine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213108MEDUVISION Mac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213115MEDUVISION Mac 2 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213122MEDUVISION Mac 4 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
04053755213139MEDUVISION HyMac 3 (10x)Heine Optotechnik GmbH & Co. KGCCW2026-06-23
00842209139149NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139156NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139163NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139170NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139187NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139194NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00842209139200NARNORTH AMERICAN RESCUE, LLCCCW2026-06-22
00810055257607Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257614Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257621Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257638Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257645Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257652Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257669Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257676Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257683Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257690Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257706Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257713Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257720Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055257737Surgical DesignSurgical Design, Inc.CCW2026-06-10
00810055251339Surgical DesignSurgical Design, Inc.CCW2026-06-09