FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925034662
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
7089-0856
Device description
Blu Epistaxis Pack, Large 10.0 cm x 1.5 cm x 2.5 cm, Bacteriostatic (10/PK)
Published
2024-11-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EMXBalloon, Epistaxis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMXBalloon, EpistaxisEar, Nose, Throat1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983276000HYDROFERA BACTERISTATIC NASAL DRESSINGHydrofera, LLC1999-09-14EMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925030831PackageGS110In Commercial Distribution
00821925034662PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925030831008219250308318219250308310821925030831
00821925034662008219250346628219250346620821925034662

GMDN Terms#

Term, Definition table
TermDefinition
Intranasal splint, non-bioabsorbable, animal-derivedA non-bioabsorbable device intended to be temporarily placed via a nostril into the nasal cavity after surgery or trauma to help minimize bleeding by tamponade effect, prevent adhesions between the mucosal surfaces, and/or provide support to the surrounding tissues during the healing period. It is made from animal-derived materials (e.g., chitosan) and is removed at the discretion of the physician. This is a single-use device.

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00821925013032EVONOS1302042018-09-10
00821925013155EVONOS1302432018-09-10
00821925013285EVONOS1301352018-09-07
00821925013292EVONOS1301362018-09-07
00821925013308EVONOS1301372018-09-07
00821925013315EVONOS1301382018-09-07
00821925013612EVONOS1303132018-09-10
00821925013629EVONOS1303162018-09-10
00821925013827EVONOS1303652018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821925042391Gyrus ACMIGyrus ACMI, LLCEMX2024-07-25
08904428722075OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722082OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722099OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722105OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722112OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722129OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722136OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722143OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722150OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722167OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722174OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722181OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722198OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722204OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722211OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722228OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722235OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722242OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722259OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722266OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722273OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722280OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722297OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722303OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722310OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722327OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722334OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722341OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11
08904428722358OSSEOUSEON MEDITECH PRIVATE LIMITEDEMX2024-06-11