FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925022300
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
70921514
Device description
DISPOSABLE MYRINGOTOMY BLADE LANCE JUVENILE STAINLESS STEEL (12/PK)
Published
2017-05-11
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925022300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925022300008219250223008219250223000821925022300

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 grommet, it is made of materials such as polytetrafluoroethylene (PTFE), polyethylene (PE), silicon elastomer, or porous polyethylene. One type, known as the malleous clip tube, attaches to the malleolus. Disposable devices associated with implantation may be included, which may be used to implant bilateral tubes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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Primary DI, Brand, Company table
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