FDA.reportPublic FDA data

OFFSET DUO ALTO TOTAL W/STAPES ADAPTER

Primary DI
00844505012881
Brand
OFFSET DUO ALTO TOTAL W/STAPES ADAPTER
Company
Grace Medical, Inc.
Model
600A
Device description
OFFSET DUO ALTO TOTAL W/STAPES ADAPTER - SIZERS INCLUDED TITANIUM/SILICONE
Published
2021-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ETAREPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
JYJGauge, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETAReplacement, Ossicular Prosthesis, TotalEar, Nose, Throat2
JYJGauge, MeasuringEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844505012881PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844505012881008445050128818445050128810844505012881

GMDN Terms#

Term, Definition table
TermDefinition
Ossicular prosthesis, totalA sterile device intended to be implanted for the total functional reconstruction of the ossicular chain (mallues, incus, and 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 polymers.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)472-2363info@gracemedical.com

Regulatory Flags#

DUNS number
030849173
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00844505014625HOUGH FLAP KNIFE999-2042026-03-27
00844505014632THOMASSIN DISSECTOR999-2052026-03-27
00844505010269TITANIUM/FLUOROPLASTIC PISTON409-6002026-02-03
00844505014526GRACE PISTON412-5252026-01-07
00844505014533GRACE PISTON412-5502026-01-07
00844505014540GRACE PISTON412-5752026-01-07
00844505012249EndoEar™ ENDOSCOPE, 3MM X 150MM, 0 DEG.EE-03002019-12-05
00844505012256EndoEar™ ENDOSCOPE, 3MM X 150MM, 30 DEG.EE-03302019-12-05
00844505012263EndoEar™ ENDOSCOPE, 3MM X 150MM, 45 DEG.EE-03452019-12-05
00844505012270EndoEar™ ENDOSCOPE, 3MM X 150MM, 70 DEG.EE-03702019-12-05
00844505014694SKULL BASE999-SB12025-09-26
00844505014700SKULL BASE999-SB22025-09-26
00844505014717SKULL BASE999-SB52025-09-26
00844505014724SKULL BASE999-SB62025-09-26
00844505014502TITANIUM PISTON461-5752025-09-18
00844505014687GRACE MEDICAL FLUOROPLASTIC PISTON402-5502025-09-18
00844505014489ECLIPSE PISTON467-3502025-08-05
00844505014519TITANIUM PISTON460-5752025-08-05
00844505014564GRACE MEDICAL FLUOROPLASTIC PISTON402-4752025-08-05
00844505014670GRACE MEDICAL FLUOROPLASTIC PISTON402-5752025-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14250368861062KURZ Meter incl. TrayHeinz Kurz GmbHJYJ2026-05-21
14250368862557Sizer OMEGA CONNECTORHeinz Kurz GmbHJYJ2026-05-21
14250368865404AC Sizer System PartialHeinz Kurz GmbHJYJ2026-05-21
14250368865503AC Sizer System TotalHeinz Kurz GmbHJYJ2026-05-21
09348811109408INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109415INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-04-24
09348811109446INKAThe Trustee for KAISER FAMILY TRUSTJYJ2026-03-18
09348811109422INKAThe Trustee for KAISER FAMILY TRUSTJYJ2025-12-01
00844505014700SKULL BASEGrace Medical, Inc.JYJ2025-09-26
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.ETA2025-07-17
00844505014663OFFSET TITANIUM WILDCAT ALTOGrace Medical, Inc.JYJ2025-07-17
00844505014649NYTEBYTEGrace Medical, Inc.JYJ2025-07-02
00763000913489N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913496BojrabMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913502Causse/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913519Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913526Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913533Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913540Causse/Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913557Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913564Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913571Causse/VincentMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913595Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913601Flex H/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913625N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913632N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913649N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913656N/AMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913663SilversteinMEDTRONIC XOMED, INC.ETA2025-06-23
00763000913717Sheehy/PolycelMEDTRONIC XOMED, INC.ETA2025-06-23