FDA.report

Integra® Jarit®

Primary DI
M2741354401
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
135-440
Catalog number
135440
Device description
Locking Device for REF# 135-445, Stone Clamp Applying Forceps
Published
2018-09-12
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
10381780181231PrimaryGS10
M2741354401SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1038178018123110381780181231

GMDN Terms

TermDefinition
Open-surgery stone-retrieval forcepsA hand-held manual surgical instrument designed to grasp and/or manipulate a calculus (i.e., a kidney or gallbladder stone) during an open surgical procedure; additional intended uses may include soft-tissue manipulation (e.g., polyp removal). It is typically made of high-grade stainless steel and is of scissors-like design with two handles attached to two long curved blades. The handles may be permanently joined or conjoined, usually by pressure, during use. The distal gripping blades may be designed with serrated and/or ringed or slotted grasping surfaces. This is a reusable device.

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
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
M2741354351Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONFFR2018-04-03