FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
10381780203056
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
510130
Catalog number
510-130
Device description
Integra® Jarit® Martin Pelvimeter
Published
2017-05-16
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
HERPELVIMETER, EXTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HERPelvimeter, ExternalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10381780203056PrimaryGS10
M2745101301SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178020305610381780203056

GMDN Terms#

Term, Definition table
TermDefinition
PelvimeterA measuring device used to determine the pelvic dimensions. This is typically the internal/external measurement of the pelvis, its diameters and capacity and is usually used in conjunction with gynaecological treatment/intervention. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No

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
G586OB6421210Novo SurgicalNOVO SURGICAL, INC.HER2023-12-18
G586OB6421410Novo SurgicalNOVO SURGICAL, INC.HER2023-12-18
G586OB96421410Novo SurgicalNOVO SURGICAL, INC.HER2023-12-18
00842331183676Novo Surgical Inc. NOVO SURGICAL, INC.HER2022-11-14
04038653154951AESCULAPAesculap AGHER2020-05-08
04038653154975AESCULAPAesculap AGHER2020-05-08
10381780495079Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
10381780495086Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
H8343022300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
H8343022350Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
10885403046735V. MuellerSTERIS CORPORATIONHER2018-08-30
10381780409328Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
M274X4133461Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
M2745101301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16