FDA.reportPublic FDA data

Integra® Jarit®

Primary DI
M274X4133461
Brand
Integra® Jarit®
Company
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Model
X413346
Device description
Collyer Pelvimeter, Graduated In Centimeters And Inches
Published
2017-05-16
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

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
10381780409328PrimaryGS10
M274X4133461SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1038178040932810381780409328

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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780533276Codman®901001BRKT901001BRKT2026-10-15
10381780533283Codman®901001POLC901001POLC2026-10-15
10381780129103Integra® Jarit®615296B615-296B2016-08-11
10381780146025Integra® Jarit®600CTVA600-CTVA2016-08-24
10381780146032Integra® Jarit®600SCR138600-SCR-1382016-08-24
10381780146049Integra® Jarit®600SPR138600-SPR-1382016-08-24
10381780146056Integra® Jarit®600SPS550600-SPS-5502016-08-24
10381780146698Integra® Jarit®610107DA610-107DA2016-08-24
10381780147053Integra® Jarit®625107RD625-107RD2016-08-24
10381780147404Integra® Jarit®630107IL630-107IL2016-08-24
10381780147541Integra® Jarit®632107IL632-107IL2016-08-24
10381780152866Integra® Ruggles®-Redmond™R6312R63122016-08-11
10381780152873Integra® Ruggles®-Redmond™R8974R89742016-08-11
10381780152880Integra® Ruggles®-Redmond™R8978R89782016-08-11
10381780154495Integra® Ruggles®-Redmond™R2381R23812016-08-11
10381780154501Integra® Ruggles®-Redmond™R2382R23822016-08-11
10381780154518Integra® Ruggles®-Redmond™R2384R23842016-08-11
10381780154525Integra® Ruggles®-Redmond™R2389R23892016-08-11
10381780154532Integra® Ruggles®-Redmond™R2396R23962016-08-11
10381780154549Integra® Ruggles®-Redmond™R2397R23972016-08-11

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
10381780203056Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
10381780409328Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
M2745101301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16