FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925015258
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
140335
Device description
MCGEE PL/SS PSTN .6DX5.00
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K760433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K760433000SHEA TORP, OTOLOGY IMPLANTRichard'S Medical Equip., Inc.1976-10-05ETA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925015258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925015258008219250152588219250152580821925015258

GMDN Terms#

Term, Definition table
TermDefinition
Ossicular prosthesis, partialA sterile device intended to be implanted for the functional reconstruction of segments of the ossicular chain (mallues, incus, and/or stapes bones) to facilitate the conduction of sound waves from the tympanic membrane to the inner ear. It is designed to treat conductive hearing loss from traumatic or surgical injury, otosclerosis, congenital fixation of the stapes, or chronic middle ear disease. The device is typically in the form of a tube made of metal [e.g., stainless steel, titanium (Ti)], polymers, or a combination of these materials.

Contacts#

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

Regulatory Flags#

DUNS number
007198742
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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