AccessGUDID - DEVICE: Integra® Jarit® (10381780203056)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 510130
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 510-130
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780203056
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Martin Pelvimeter

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
12980	Pelvimeter	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HER	PELVIMETER, EXTERNAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: No

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: de63dd99-fd6a-46a5-822b-4901dcd7d7a4
Public Version Date: April 24, 2023
Public Version Number: 5
DI Record Publish Date: May 16, 2017