FDA.reportPublic FDA data

TISSUE SUPPORT DIAL

Primary DI
00844505010405
Brand
TISSUE SUPPORT DIAL
Company
Grace Medical, Inc.
Model
990-006
Device description
CARTILAGE MICROTOME TISSUE SUPPORT DIAL
Published
2018-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZTCutter, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844505010405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844505010405008445050104058445050104050844505010405

GMDN Terms#

Term, Definition table
TermDefinition
ENT cartilage cutterA portable, manual surgical instrument intended to cut a harvested cartilage specimen (e.g., tragus-derived autograft) to an accurate predetermined thickness for patient implantation during an ear/nose/throat (ENT) procedure (e.g., middle ear surgery). It typically consists of an adjustable cutting assembly with a handle, base, and thickness dial used in conjunction with a removable ENT cartilage cutter blade. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
030849173
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
G149TBSB7890TBS BASICSACME ENTERPRISE.FZT2026-05-21
14250368861550KURZ Precise Cartilage Knife SetHeinz Kurz GmbHFZT2026-05-21
08717903490594Humeca MAX MesherHumeca B.V.FZT2026-03-31
05010058084346InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-12-16
00192896122499Cartilage Graft CutterSONTEC INSTRUMENTS, INC.FZT2025-11-21
03662663113151Virage OCT Spinal Fixation SystemHighridge Medical, LLCFZT2025-11-12
04049197556552RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFZT2025-10-15
05033955023263Swann-Morton LimitedSWANN-MORTON LIMITEDFZT2025-08-25
05010058080492InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-06-23
05010058080836InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-06-23
10649111400117Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
10649111400124Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
10649111400131Sklar InstrumentsSKLAR CORPORATIONFZT2025-06-15
E896294920SCHWERTA. Schweickhardt GmbH & Co. KGFZT2025-05-22
05010058081987InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-05-21
05010058999749InstrapacROBINSON HEALTHCARE LIMITEDFZT2025-05-21
10649111078910Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111079092Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111488115Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
10649111488122Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
05033955035266Swann Morton Ltd.SWANN-MORTON LIMITEDFZT2024-10-15
05033955036263Swann Morton Ltd.SWANN-MORTON LIMITEDFZT2024-10-15
00850037506262MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-09-18
00850037506231MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00850037506248MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00850037506255MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-08-26
00714646000781SutureOutBionix, LLCFZT2024-04-23
00714646001184SutureOutBionix, LLCFZT2024-04-23
10197106247327CARDINAL HEALTHCardinal Health 200, LLCFZT2023-09-14
05010058070837InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08