FDA.reportPublic FDA data

GYRUS ACMI, INC

Primary DI
00821925015548
Brand
GYRUS ACMI, INC
Company
Gyrus ACMI, LLC
Model
140867
Device description
MEDIUM CANAL WALL PROSTHESIS POROUS HYDROXYLAPATITE
Published
2015-10-24
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZDProsthesis, Ear, Internal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZDProsthesis, Ear, InternalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844960000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844960000CANAL WALL PROSTHESISRichards Medical Co., Inc.1985-02-26FZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925015548PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925015548008219250155488219250155480821925015548

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene craniofacial tissue reconstructive materialA sterile implantable device intended to support, contour, and provide structure for the craniofacial anatomy (i.e., head and face including the chin, cheeks, nose, eye sockets and ears) during reconstructive and plastic surgery procedures. It is typically a high-density polyethylene (PE) material with an interconnecting pore structure that supports tissue ingrowth. The device is available in blocks, sheets, wedges and spheres that can be cut by the surgeon to meet the patient's specific needs. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18002623540xxx@xxx.xxx

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
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
M724EPTFEAAH55L1Composite™ ePTFE- Coated Auricular Anti-HelixIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH55R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH58L1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH58R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH61L1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH61R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH63L1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAAH63R1Composite™ ePTFE-Coated Auricular Anti-Helix IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF55L1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF55R1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF58L1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF58R1Composite™ ePTFE-Coated Auricular Base FrameIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF61L1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF61R1Composite™ ePTFE-Coated Auricular Base FrameIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF63L1Composite™ ePTFE-Coated Auricular Base FrameIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEABF63R1Composite™ ePTFE-Coated Auricular Base Frame IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB55L1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB55R1Composite™ ePTFE-Coated Auricular Posterior BlockIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB58L1Composite™ ePTFE-Coated Auricular Posterior BlockIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB58R1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB61L1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB61R1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB63L1Composite™ ePTFE-Coated Auricular Posterior BlockIMPLANTECH ASSOCIATES, INC.FZD2023-07-06
M724EPTFEAPB63R1Composite™ ePTFE-Coated Auricular Posterior Block IMPLANTECH ASSOCIATES, INC.FZD2023-07-06
00821925015531GYRUS ACMI, INCGyrus ACMI, LLCFZD2015-10-24
00821925015555GYRUS ACMI, INCGyrus ACMI, LLCFZD2015-10-24