FDA.reportPublic FDA data

GYRUS ACMI, INC

Primary DI
00821925011847
Brand
GYRUS ACMI, INC
Company
Gyrus ACMI, LLC
Model
130109
Device description
HOUGH PICK LARGE CURVE 12.7 MM TIP LENGTH STAINLESS STEEL EBONY FINISH
Published
2018-09-07
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
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925011847PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925011847008219250118478219250118470821925011847

GMDN Terms#

Term, Definition table
TermDefinition
ENT mobilizerA hand-held, manual, stainless steel surgical instrument with a small diameter shaft tapering from the handle typically intended to be used to remobilize the footplate of the stapes to relieve conductive hearing impairment due to otosclerosis or middle ear disease. The distal tip of the shaft is bent at a slight angle to the shaft and expands to form a small platform that is larger than the distal shaft. The distal surface of the platform is shaped into a set of small ridges or projections which can be of several geometric shapes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091315ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-09
00198506091322ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-09
00198506091346ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-09
00198506091155ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091162ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091186ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091193ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
00198506091223ELMED INCORPORATEDELMED INCORPORATEDLRC2026-06-03
14250368820892Soft CliP HookHeinz Kurz GmbHLRC2026-05-21
14250368861437Trocar HandleHeinz Kurz GmbHLRC2026-05-21
14250368862007Cartilage PunchHeinz Kurz GmbHLRC2026-05-21
00198506090790ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-15
00198506090752ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-13
00198506090769ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-13
00190776421366MillenniumAvalign Technologies, Inc.LRC2026-05-05
00198506090479ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-05
00190776420758MillenniumAvalign Technologies, Inc.LRC2026-04-30
00190776420871MillenniumAvalign Technologies, Inc.LRC2026-04-30
00198506090387ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-30
00198506090394ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-30
00757770535620Bausch + LombBausch & Lomb IncorporatedLRC2026-04-30
00198506090318ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-28
00198506090257ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-21
00198506090288ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-21
00190776419950MillenniumAvalign Technologies, Inc.LRC2026-04-15
00190776419578MillenniumAvalign Technologies, Inc.LRC2026-04-14
00190776419585MillenniumAvalign Technologies, Inc.LRC2026-04-14
00190776418977MillenniumAvalign Technologies, Inc.LRC2026-04-13
00198506089954ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-03
00198506089497ELMED INCORPORATEDELMED INCORPORATEDLRC2026-04-02