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
00821925014206Gyrus ACMI1404202015-10-24
00821925014213Gyrus ACMI1404212015-10-24
00821925014237Gyrus ACMI1404232015-10-24
00821925014244Gyrus ACMI1404252015-10-24
00821925014251Gyrus ACMI1404262015-10-24
00821925014268Gyrus ACMI1404272015-10-24
00821925014299Gyrus ACMI1404342015-10-24
00821925014558Gyrus ACMI1403402015-10-24
00821925014565Gyrus ACMI1403412015-10-24
00821925014572Gyrus ACMI1404102015-10-24
00821925014589Gyrus ACMI1404112015-10-24
00821925014596Gyrus ACMI1404122015-10-24
00821925014619Gyrus ACMI1404152015-10-24
00821925014626Gyrus ACMI1404162015-10-24
00821925014640Gyrus ACMI1404182015-10-24
00821925014916Gyrus ACMI1403302015-10-24
00821925015210Gyrus ACMI1403312015-10-24
00821925015227Gyrus ACMI1403322015-10-24
00821925015234Gyrus ACMI1403332015-10-24
00821925015241Gyrus ACMI1403342015-10-24

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