FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780193036
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
P1476B
Catalog number
P1476B
Device description
"Integra® Jarit® Volkmann Scoop, 8-3/4"", Double-Ended, 4mm x 7mm and 6mm x 12mm Cups"
Published
2018-04-03
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
FHLSCOOP

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHLScoopGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780193036PrimaryGS10
M274P1476B1SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178019303610381780193036

GMDN Terms#

Term, Definition table
TermDefinition
Gastro-urological scoopA heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long thin shaft that is used to access and scrape tissue from the common hepatic/bile duct system during a gastroenterological/urological (GU) procedure. The device is typically made of high-grade stainless steel and has a malleable (bendable) distal tip to assist with accessibility to the various sites; it has a handle at the proximal end. The scoop is available in various shapes and sizes. 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

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Primary DI, Brand, Company table
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B382SD9162111090Surgical DirectSurgical Direct, Inc.FHL2026-07-28
04049047109723GimmiGimmi GmbHFHL2025-05-27
04049047109747GimmiGimmi GmbHFHL2025-05-27
04049047109778GimmiGimmi GmbHFHL2025-05-27
04049047109785GimmiGimmi GmbHFHL2025-05-27
04049047109792GimmiGimmi GmbHFHL2025-05-27
04049047109808GimmiGimmi GmbHFHL2025-05-27
08403207009654Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009661Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009678Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
08403207009685Anmuth Medical InternationalAnmuth Medical International, LLCFHL2025-03-24
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00840343721763GEN2SURGIX MEDICAL LLCFHL2024-04-05
00810158210158PRINCETONPrinceton Medical Group, Inc.FHL2024-03-05
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