AccessGUDID - DEVICE: COIL SHEATH (04953170033025)

GUDID

Device Identifier (DI) Information

Brand Name: COIL SHEATH
Version or Model: MAJ-403
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170033025
Issuing Agency: GS1
Commercial Distribution End Date: August 09, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: MAJ-403 REPLACEMENT COIL SHEATH FOR EMER

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":	Yes
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?
64360	Manual biliary stone fragmenter handle, noninvasive, reusable	A noninvasive, manual device intended to be connected to a manual biliary stone fragmenter (not included) and used to create adequate torque (power) to crush a biliary stone once it has been grasped by the distal mechanism of the fragmenter during an endoscopic procedure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LQC	Lithotriptor, biliary mechanical

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 [?]
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: 07088497-bfb9-4c53-aeca-213cf68a973a
Public Version Date: January 16, 2023
Public Version Number: 9
DI Record Publish Date: September 21, 2016