FDA.report

Integra® Jarit®

Primary DI
M2741354351
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
135-435
Catalog number
135435
Device description
Stone Intestinal Clamp, 4-3/8", With Locking Device
Published
2018-04-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FFRDEVICE, LOCKING, FOR INTESTINAL CLAMP

Product Code Classifications

CodeDeviceSpecialtyClass
FFRDevice, Locking, For Intestinal ClampGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10381780167235PrimaryGS10
M2741354351SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178016723510381780167235

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags

DUNS number
081277700
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

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00887482000540Symmetry Surgical®SYMMETRY SURGICAL INC.FFR2022-08-30
00192896105942Best Intestinal ClampSONTEC INSTRUMENTS, INC.FFR2020-12-21
04046963142476AESCULAPAesculap AGFFR2020-05-04
70885403275953V. MuellerCAREFUSION 2200, INCFFR2020-04-15
70885403275960V. MuellerCAREFUSION 2200, INCFFR2020-04-15
70885403275977V. MuellerCAREFUSION 2200, INCFFR2020-04-15
00888118055101FORCEPSKLS-Martin L.P.FFR2018-09-26
00888118055118FORCEPSKLS-Martin L.P.FFR2018-09-26
00888118055125FORCEPSKLS-Martin L.P.FFR2018-09-26
00888118055132FORCEPSKLS-Martin L.P.FFR2018-09-26
04953170257124ET Control Device VOLYMPUS MEDICAL SYSTEMS CORP.FFR2018-09-21
00192896045446KNUTSON URETHROGRAPHY SETSONTEC INSTRUMENTS, INC.FFR2018-09-20
00192896072091HAYES INTESTINAL CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-19
10885403133473V. MuellerCAREFUSION 2200, INCFFR2018-09-18
10885403133664V. MuellerCAREFUSION 2200, INCFFR2018-09-18
10885403133701V. MuellerCAREFUSION 2200, INCFFR2018-09-18
10885403133718V. MuellerCAREFUSION 2200, INCFFR2018-09-18
00192896011571THORLAKSON LOWER OCCLUSIVE CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-18
10885403129155V. MuellerCAREFUSION 2200, INCFFR2018-09-17
10885403129162V. MuellerCAREFUSION 2200, INCFFR2018-09-17
M2741354401Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFFR2018-09-12
00192896011502FEHLAND SIGMOID ANASTOMOSIS CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011519RESANO SIGMOID ANASTOMOSIS FORCEPS SONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011526HAYES INTESTINAL CLAMP SONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011540MIKULICZ CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011564THORLAKSON LOWER OCCLUSIVE CLAMPSONTEC INSTRUMENTS, INC.FFR2018-09-12
00192896011533BEST INTESTINAL CLAMP SONTEC INSTRUMENTS, INC.FFR2018-09-11
10885403050770V. MuellerCAREFUSION 2200, INCFFR2018-08-30
M274X272831Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFFR2018-05-03
M2741354301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFFR2018-04-03