FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780374435
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
X384120
Catalog number
X384120
Device description
"Integra® Jarit® Synthetic Cast Cutter, 7-1/2"", Blunt, One Serrated Blade"
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LGGINSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL
LRWSCISSORS, GENERAL, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGGInstrument, Cast Application/Removal, ManualOrthopedic1
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780374435PrimaryGS10
M274X3841201SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178037443510381780374435

GMDN Terms#

Term, Definition table
TermDefinition
Cast cutting shearsA large, scissors-like, hand-held instrument whose blades distal to the pivot point terminate in various jaw configurations, capable of cutting heavy layers of plaster or synthetic material used to form hardened casts, i.e., that which has already been used to form a cast around a patient's limb or body part. The tip of one of the distal blades forming the scissors-like cutting mechanism is usually rounded along it bottom edge to prevent injury to the patient as the cast is cut. This device is typically made of high-grade stainless steel and will usually be provided with a spring mechanism to assist in opening the jaws. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
10381780406914Integra® Jarit®X312143X3121432018-05-03
10381780421245Integra® Miltex®20-103220-10322017-12-21
10381780076155Integra®371106837110682018-09-17
10381780076162Integra®371106937110692018-09-17
10381780076179Integra®371107137110712018-09-17
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435479MillenniumAvalign Technologies, Inc.LRW2026-10-20
00190776436629MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776436728MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776439712MilleniumAvalign Technologies, Inc.LRW2026-10-20
B356111PL87514ST0steriSTATAmerican MedicalsLRW2026-10-20
00190776435325MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435332MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435400MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435189MillenniumAvalign Technologies, Inc.LRW2026-10-16
00190776434915MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435042MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435059MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435066MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435073MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776434649MillenniumAvalign Technologies, Inc.LRW2026-10-12
00190776434793MillenniumAvalign Technologies, Inc.LRW2026-10-12
00190776433864MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436278MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436292MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776433635MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434403MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434496MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434502MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434519MillenniumAvalign Technologies, Inc.LRW2026-10-07
G141510457190Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-10-07
00190776433987MillenniumAvalign Technologies, Inc.LRW2026-10-06
00190776433994MillenniumAvalign Technologies, Inc.LRW2026-10-06
10841767100537Trinity Sterile, Inc.Trinity Sterile, Inc.LRW2026-10-06
00190776435882MillenniumAvalign Technologies, Inc.LRW2026-09-30
04059453158284Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-09-30