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
10381780024507Integra® Jarit®100539100-5392018-01-22
10381780024514Integra® Jarit®100540100-5402018-01-22
10381780031901Integra® Miltex®27-20227-2022015-09-22
10381780031918Integra® Miltex®27-20427-2042015-09-22
10381780031925Integra® Miltex®27-20627-2062015-09-22
10381780031932Integra® Miltex®27-20827-2082015-09-22
10381780031949Integra® Miltex®27-21027-2102015-09-22
10381780031956Integra® Miltex®27-21227-2122015-09-22
10381780063865Integra® Miltex®4-515C4-515C2018-02-15
10381780063872Integra® Miltex®4-5224-5222018-02-15
10381780063896Integra® Miltex®461146112018-02-15
10381780063902Integra® Miltex®461546152018-02-15
10381780064206Integra® Miltex®33-3833-382018-02-14
10381780128779Integra® Miltex®30-174030-17402016-08-03
10381780133810Integra® Jarit®320437320-4372016-08-12
10381780134503Integra® Jarit®6531016531012018-01-15
10381780136408Integra® Jarit®X37254X372542016-08-14
10381780142874Integra® Jarit®230250230-2502016-08-14
10381780143048Integra® Jarit®320195320-1952016-08-14
10381780143055Integra® Jarit®320196320-1962016-08-14

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