FDA.reportPublic FDA data

Gyrus ACMI

Primary DI
00821925022331
Brand
Gyrus ACMI
Company
Gyrus ACMI, LLC
Model
70921928
Device description
SMART STAPES PISTON .8 X 5.25 MM
Published
2016-10-06
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K003214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003214000SMITH & NEPHEW PISTONSGyrus Ent LLC2000-10-31ETB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925022331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925022331008219250223318219250223310821925022331

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.

Sterilization Methods#

Method table
Method

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
00821925033900DIEGO701390022024-07-25
00821925033917DIEGO701390062024-07-24
00821925034419DIEGO701390332024-07-23
00821925034730Gyrus ACMI703531002017-05-11
00821925034754Gyrus ACMI703531122017-05-11
00821925035935OLYMPUS37402016-10-03
00821925001428GYRUS ACMICW-USLPC2016-10-13
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30

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