AccessGUDID - DEVICE: Integra® Jarit® (10381780192558)

GUDID

Device Identifier (DI) Information

Brand Name: Integra® Jarit®
Version or Model: 505100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 505-100
Company Name: INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Primary DI Number: 10381780192558
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081277700 *Terms of Use

Device Description: Integra® Jarit® Thomas-Gaylor Uterine Biopsy Forceps, 9-1/4", Curved Jaws, Angled Shanks, 6mm Cups

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?
11775	Open-surgery biopsy forceps, reusable	A hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HFB	FORCEPS, BIOPSY, GYNECOLOGICAL

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: 9-1/4"
Device Size Text, specify: 6mm Cups

Device Record Status

Public Device Record Key: be4a5db2-1868-4b61-b013-85e7e86762de
Public Version Date: April 25, 2023
Public Version Number: 6
DI Record Publish Date: April 03, 2018