FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780185147
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
260135
Catalog number
260-135
Device description
"Langenbeck Metacarpal Saw, 9-1/4"", 4-1/2"" Blade"
Published
2018-01-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDRSAW, MANUAL AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDRSaw, Manual And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780185147PrimaryGS10
M2742601351SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178018514710381780185147

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical saw, rigidA hand-held manual surgical instrument typically used in orthopaedic surgery for cutting bone or other body tissue through a sawing action performed by the user. It typically consists of a metal frame with an attached handle that firmly holds an exchangeable blade usually with the cutting teeth set in a straight line; or it may have an integral blade as part of the design which can have a straight or curved cutting edge. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
081277700
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780156802Integra® Ruggles®-Redmond™RN2528RN25282016-08-14
10381780167075Integra® Jarit®500105500-1052018-04-09
10381780394761Integra® Jarit®500100500-1002018-04-09
10381780394778Integra® Jarit®500110500-1102018-04-09
10381780394808Integra® Jarit®500135500-1352018-04-09
10381780435860Integra® Miltex®30-3030-302018-01-24
10381780435907Integra® Miltex®30-5530-552018-01-24
10381780435952Integra® Miltex®30-6230-622018-01-24
10381780488248Integra® Miltex®MH30-10MH30-102018-08-20
10381780488262Integra® Miltex®MH30-15MH30-152018-08-20
10381780488279Integra® Miltex®MH30-20MH30-202018-08-20
10381780488286Integra® Miltex®MH30-30MH30-302018-08-20
10381780488293Integra® Miltex®MH30-50MH30-502018-08-20
10381780488361Integra® Miltex®MH30-55MH30-552018-08-20
10381780488378Integra® Miltex®MH30-60MH30-602018-08-20
10381780488385Integra® Miltex®MH30-62MH30-622018-08-20
10381780500490Integra® Miltex®30-1030-102018-09-18
10381780500520Integra® Miltex®30-1530-152018-09-18
10381780500605Integra® Miltex®30-2030-202018-09-18
10381780077244Integra®371231037123102018-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411589MillenniumAvalign Technologies, Inc.GDR2026-08-07
B382SD9140251010Surgical DirectSurgical Direct, Inc.GDR2026-07-28
08403207009517Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
08403207009579Anmuth Medical InternationalAnmuth Medical International, LLCGDR2025-06-09
04049047061984GimmiGimmi GmbHGDR2025-05-20
04049047062080GimmiGimmi GmbHGDR2025-05-20
00810123208593Adler Instrument CompanyAdler, Inc.GDR2025-02-12
04049197537292RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-10-16
04049197499248RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499255RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197499262RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-09-20
04049197149983RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197149990RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150002RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150125RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197150163RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205146RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
04049197205153RZ Medizintechnik GmbHRZ-Medizintechnik GmbHGDR2024-06-28
00190776385774MillenniumAvalign Technologies, Inc.GDR2024-05-09
00842517107533Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00842517107540Karl SchumacherKarl Schumacher Dental, LLCGDR2024-02-28
00888515192003BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192010BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192027BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192034BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192058BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192065BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192072BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192089BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28
00888515192096BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.GDR2024-02-28