FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925032552
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
70145771
Device description
SHEEHY-TYPE COLLAR BUTTON TWIN PACK SIXTY FLUOROPLASTIC 1.27 MM ID (60/PK)
Published
2024-07-24
Public version status
Update
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
ETDTube, Tympanostomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETDTube, TympanostomyEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992222000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992222000FLUOROPLASTIC VENTILATION TUBESGyrus Ent LLC1999-08-26ETD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925025011PackageGS160In Commercial Distribution
00821925032552PrimaryGS10
80821925032558Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925025011008219250250118219250250110821925025011
00821925032552008219250325528219250325520821925032552
8082192503255880821925032558

GMDN Terms#

Term, Definition table
TermDefinition
Tympanostomy tubeA small, hollow cylinder intended to be implanted, by insertion through the tympanic membrane, for ventilation or drainage of the middle ear. Otherwise known as a myringotomy tube, grommet or an aural vent tube, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleus clip tube, attaches to the malleus. Disposable devices associated with implantation may be included with the device, which may be used to implant bilateral tubes.

Regulatory Flags#

DUNS number
007198742
Device count
2
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925013964GYRUS ACMI, INC1400032015-10-24
00821925014039EVONOS GMBH & Co. Kg1400532015-10-24
00821925014060EVONOS GMBH & Co. Kg1400592015-10-24
00821925014176GYRUS ACMI, INC1400872015-10-24
00821925014190GYRUS ACMI, INC1401022015-10-24
00821925014497GYRUS ACMI, INC1401032015-10-24
00821925014534GYRUS ACMI, INC1400702015-10-24
00821925015449Gyrus ACMI1401812015-10-24
00821925015470Gyrus ACMI1401852015-10-24
00821925015487Gyrus ACMI1401862015-10-24
00821925015500GYRUS ACMI, INC1401882015-10-24
00821925016057Gyrus ACMI1401642015-10-24
00821925016064Gyrus ACMI1401652015-10-24
00821925016071Gyrus ACMI1401662015-10-24
00821925016088Gyrus ACMI1401672015-10-24
00821925016095GYRUS ACMI, INC1401682015-10-24
00821925016125Gyrus ACMI1401802015-10-24
00821925016934GYRUS ACMI, INC1401492015-10-24
00821925016965Gyrus ACMI1401622015-10-24
00821925017207GYRUS ACMI, INC1401082015-10-24

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Primary DI, Brand, Company table
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