GYRUS ACMI, INC

Primary DI
00821925020177
Brand
GYRUS ACMI, INC
Company
Gyrus ACMI, LLC
Model
290136
Device description
DISPOSABLE 'DONUT' HEAD REST LARGE (6/PK)
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
00821925020177PrimaryGS10
00821925040939Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925020177008219250201778219250201770821925020177
00821925040939008219250409398219250409390821925040939

GMDN Terms#

Term, Definition table
TermDefinition
ENT headrestA device designed to be attached to an appropriate operating table to support and stabilize the head of a recumbent patient during an ear/nose/throat (ENT) procedure. The headrest is typically made of metal and synthetic materials that incorporate a cup-shaped, or indented with a central hole, cushion or pad that provides a softer surface for the patient's head to rest in. It is available in various shapes and sizes and will typically include mechanical mechanisms that enable adjustments in relation to the table top. This is a reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800)262-3540xxx@xxx.xxx

Regulatory Flags#

DUNS number
007198742
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M6333816500JEDMEDJEDMED INSTRUMENT COMPANYETD2023-05-08
00385640073509NASummit Medical, Inc.ETD2023-01-11
00385640068604Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068611Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068628Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068635Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068659Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068666Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068673Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068680Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068697Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068703Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068710Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068727Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068734Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068741Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068758Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068765Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068796Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068802Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068819Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068826Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068833Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068840Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068857Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068864Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068871Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068888Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068895Summit MedicalSummit Medical, Inc.ETD2022-10-06
00385640068901Summit MedicalSummit Medical, Inc.ETD2022-10-06