FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925003453
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
LAS-B
Device description
Lens Cleaner
Published
2016-10-05
Public version status
Update
Distribution status
Not 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
00821925003453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925003453008219250034538219250034530821925003453

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic antifog solutionA liquid substance used to prevent the occurrence of condensed vapour (fog) on the lens of an endoscopic instrument during treatment. It will typically be used on the lens of an endoscopic camera where the warmth from an enclosed body cavity creates the conditions to produce fog on the lens. This device will typically be contained in a spray can, bottle, or squeeze bottle. 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
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15056094505435PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
15056094505480PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
15056094505497PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505319PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505326PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505333PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505340PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505357PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505364PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505371PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505395PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505401PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505418PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505425PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505456PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505463PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
25056094505470PROACT VLSPROACT MEDICAL LIMITEDCCW2026-10-14
00190776434038MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434045MillenniumAvalign Technologies, Inc.CCW2026-10-09
00190776434052MillenniumAvalign Technologies, Inc.CCW2026-10-09
06971834830016Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830023Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830030Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830047Vimac Video LaryngoscopeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830542Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830559Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830566Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830573Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830580Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30
06971834830597Sterilized Disposable BladeHEBEI VIMED MEDICAL DEVICE COMPANY, LTD.CCW2026-09-30