AccessGUDID - DEVICE: Grasping Forceps 5mm O.D. (with Rubber Tips) (04953170154379)

GUDID

Device Identifier (DI) Information

Brand Name: Grasping Forceps 5mm O.D. (with Rubber Tips)
Version or Model: T1079
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170154379
Issuing Agency: GS1
Commercial Distribution End Date: August 19, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: No description.

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?
65544	Laparoscope manipulation forceps	A rigid manual device intended to allow grasping and manipulation of the distal end of an endoscope during a percutaneous endoscopic procedure; it is not intended for grasping of tissues. It is intended to be introduced through a separate percutaneous (laparoscopic) port/cannula for grasping and manoeuvring of the endoscope (e.g., into the biliary tract). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4968f3da-0d64-417d-a038-1ea4d1efbe17
Public Version Date: March 11, 2024
Public Version Number: 8
DI Record Publish Date: June 08, 2017