FDA.reportPublic FDA data

A. Titan Instruments

Primary DI
00841685108663
Brand
A. Titan Instruments
Company
A. TITAN INSTRUMENTS, INC.
Model
BFC-4.5 mm
Device description
Bone Funnel, Curved 4.5 mm holds 2.0 cc of bone material, red
Published
2023-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
DZNInstruments, Dental Hand

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841685108663PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841685108663008416851086638416851086630841685108663

GMDN Terms#

Term, Definition table
TermDefinition
Bone graft funnelA device designed to deliver bone graft filling material (autologous, allogeneic, xenogeneic, or synthetic) during an orthopaedic procedure to enable the filling of bone gaps intended to be fused. It is a funnel-shaped device; the funnel being bowl-shaped with the ability to hold back the filling material depending upon the angle of tilt applied by the surgeon, and a long, thin tube that can be inserted into the site to be filled, e.g., a cancellous bone graft being discharged into the posterior disc space of a vertebra. An orthopaedic graft inserter can be pushed down the funnel tube to press the graft material into the site. This is a reusable device.

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
037738874
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
00841685104207A. Titan InstrumentsRubber Tips2023-01-25
00841685104368A. Titan InstrumentsPowder2023-01-25
00841685111373A. Titan Instruments1000 (KIT)2023-01-25
00841685111571A. Titan InstrumentsK-3632023-01-20
00841685111588A. Titan InstrumentsK-3692023-01-20
00841685103453A. Titan InstrumentsT0652023-01-25
00841685112561A. Titan InstrumentsJAC 1S-2S UL2023-08-09
00841685112523A. Titan InstrumentsAMLB-12023-06-28
00841685112530A. Titan InstrumentsAMLB-22023-06-28
00841685112547A. Titan InstrumentsAMLBL-12023-06-28
00841685112554A. Titan InstrumentsAMLBL-22023-06-28
00841685108724A. Titan InstrumentsMB-12023-01-25
00841685112363A. Titan InstrumentsAMLC-42023-04-05
00841685112370A. Titan InstrumentsAMMC-32023-04-05
00841685112387A. Titan InstrumentsAMMC-72023-04-05
00841685112394A. Titan InstrumentsAMMC-102023-04-05
00841685112400A. Titan InstrumentsAMMC-112023-04-05
00841685112417A. Titan InstrumentsAMMC-122023-04-05
00841685112424A. Titan InstrumentsAMMC-132023-04-05
00841685112431A. Titan InstrumentsAMMC-142023-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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10860013564732CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564756CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564763CurvaGc Orthodontics America Inc.DZN2026-05-28
10860013564770CurvaGc Orthodontics America Inc.DZN2026-05-28
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08404535019070Brasseler USAPeter Brasseler Holdings, LLCDZN2026-04-29
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