FDA.reportPublic FDA data

A. Titan Instruments

Primary DI
00841685102463
Brand
A. Titan Instruments
Company
A. TITAN INSTRUMENTS, INC.
Model
Weider 2
Device description
Retractor, large
Published
2023-01-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841685102463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841685102463008416851024638416851024630841685102463

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held dental retractorA hand-held, non-self-retaining dental instrument intended to be used to manually displace soft tissues of the oral cavity to improve their visualization and access, and to afford them protection during oral surgical procedures. It is typically a metallic device and includes a shaped/hooked blade with a handle/holding portion. 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
Primary DIBrandCompanyProduct codePublished
00810230800666DCI PartsDCI International, LLCEIF2026-06-26
00810230800673DCI PartsDCI International, LLCEIF2026-06-26
D2486054630Spandex Advanced Junior/Small (Black)HAGER WORLDWIDE, INC.EIF2026-06-07
D2486054640Spandex Advanced Standard/Med (Pink)HAGER WORLDWIDE, INC.EIF2026-06-07
D2486054651Spandex Advanced - 3 Size Combo Kit- Black (1 Junior/Sm, 1 Standard/Med, 1 LargeHAGER WORLDWIDE, INC.EIF2026-06-07
D2486054661Spandex Advanced - 3 Size Combo Kit- Pink (1 Junior/Sm, 1 Standard/Med, 1 Large)HAGER WORLDWIDE, INC.EIF2026-06-07
00840456223093JMUJMU DENTAL, INCEIF2026-06-05
00840456223109JMUJMU DENTAL, INCEIF2026-06-05
00840456223116JMUJMU DENTAL, INCEIF2026-06-05
00840456223123JMUJMU DENTAL, INCEIF2026-06-05
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
D248938521Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
D2486054610Spandex Advanced Junior (Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
D2486054620Spandex Advanced Large ( Pink)HAGER WORLDWIDE, INC.EIF2025-10-22
07630716603658Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603665Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603672Geistlich PanoramaDSSM AGEIF2025-09-17
07630716603689Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984601TissuePro™ Distal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12