FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925016484
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
140745
Device description
TRAPEZE RIBBON LOOP 5 MM LENGTH PLATINUM
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
ETBProsthesis, Partial Ossicular Replacement

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETBProsthesis, Partial Ossicular ReplacementEar, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K760434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K760434000TRAPEZE PLATINUM RIBBON LOOP, OTOLOGYRichard'S Medical Equip., Inc.1976-10-05ETB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925016484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925016484008219250164848219250164840821925016484

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
1(800)262-3540xxx@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
00844505010269TITANIUM/FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2026-02-03
00844505014526GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014533GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014540GRACE PISTONGrace Medical, Inc.ETB2026-01-07
00844505014502TITANIUM PISTONGrace Medical, Inc.ETB2025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-09-18
00844505014489ECLIPSE PISTONGrace Medical, Inc.ETB2025-08-05
00844505014519TITANIUM PISTONGrace Medical, Inc.ETB2025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTONGrace Medical, Inc.ETB2025-08-05
00844505014649NYTEBYTEGrace Medical, Inc.ETB2025-07-02
00763000913731N/AMEDTRONIC XOMED, INC.ETB2025-06-23
00821925035478Gyrus ACMIGyrus ACMI, LLCETB2024-07-25
00763000036591Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036607Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036614Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036621Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036638Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
00763000036645Big Easy® PistonMEDTRONIC XOMED, INC.ETB2024-05-12
EHKM10022601CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022641CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022661CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022681CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022701CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022721CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022731CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10022741CliP Partial Prosthesis TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10023641CliP Partial FlexiBAL TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10023661CliP Partial FlexiBAL TitaniumHeinz Kurz GmbHETB2023-09-29
EHKM10023681CliP Partial FlexiBAL TitaniumHeinz Kurz GmbHETB2023-09-29