AccessGUDID - DEVICE: Single Use BML Handle V (04953170433658)

GUDID

Device Identifier (DI) Information

Brand Name: Single Use BML Handle V
Version or Model: MAJ-2502
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N6154330
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170433658
Issuing Agency: GS1
Commercial Distribution End Date:
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:	Yes
Prescription Use (Rx):	No
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?
66275	Manual biliary stone fragmenter handle, noninvasive, single-use	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 single-use 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: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: 910a632a-5c16-48d3-b88e-165bde22d288
Public Version Date: September 26, 2022
Public Version Number: 1
DI Record Publish Date: September 16, 2022