FDA.reportPublic FDA data

TITAN

Primary DI
10603295259756
Brand
TITAN
Company
DEPUY (IRELAND)
Model
L44519
Catalog number
L44519
Device description
TITAN
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTQBROACH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10603295259756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1060329525975610603295259756

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
989365556
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10603295085980GLOBAL UNITE2100-70-2502100702502018-06-15
10603295088196GLOBAL ADVANTAGE2128-02-0502128020502018-09-24
10603295130192ATTUNE2544-01-0032544010032018-09-24
10603295130208ATTUNE2544-01-0042544010042018-09-24
10603295130222ATTUNE2544-01-0062544010062018-09-24
10603295395423ATTUNE2544-01-0092544010092018-09-24
10603295431275DEPUY REACH9505-05-1349505051342018-09-24
10603295431596DEPUY REACH9505-05-1359505051352018-09-24
10603295440222ATTUNE2546-00-4242546004242016-12-05
10603295443780ATTUNE2544-91-0012544910012020-06-11
10603295443797ATTUNE2544-91-0022544910022020-06-11
10603295443803ATTUNE2544-91-0032544910032020-06-11
10603295443810ATTUNE2544-91-0042544910042020-06-11
10603295451297ATTUNE2546-00-4162546004162016-12-05
10603295493549ATTUNE2544-11-0032544110032017-04-10
10603295496229ATTUNE2546-00-5162546005162018-01-24
10603295543879RECLAIM74-1000-1157410001152026-01-23
10603295543916RECLAIM74-1000-1207410001202026-01-23
10603295503309ATTUNE1506-61-3101506613102026-01-13
10603295503316ATTUNE1506-61-3201506613202026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889797112307Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HTQ2025-08-26
00889797112314Incompass Total Ankle SystemWRIGHT MEDICAL TECHNOLOGY, INC.HTQ2025-08-26
00810111222679BroachTreace Medical Concepts, Inc.HTQ2025-08-06
00822409130962N/AOrtho Development CorporationHTQ2025-06-25
00822409130979N/AOrtho Development CorporationHTQ2025-06-25
00840314269751gSourceGSOURCE LLCHTQ2025-06-16
00840286841740Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841757Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841764Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841771Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841788Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841795Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841801Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841818Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841825Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841832Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841849Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841856Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841863Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841870Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841887Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286841894Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-22
00840286840491TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840507TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840514TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840521TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840538TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840545TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840552Consensus Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21
00840286840569TaperSet Hip SystemShalby Advanced Technologies, Inc.HTQ2025-05-21