AccessGUDID - DEVICE: Integra® Jarit® (10381780202219)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 500337
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500-337
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780202219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Duncan Endometrial Biopsy Curette

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?
32594	Intrauterine curette, manual	A heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HCY	CURETTE, UTERINE

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 11-1/2"
Length: 10 Millimeter
Width: 2.4 Millimeter

Device Record Status

Public Device Record Key: 763acf06-98fe-429f-9c42-1731180f0842
Public Version Date: June 25, 2024
Public Version Number: 5
DI Record Publish Date: April 09, 2018