AccessGUDID - DEVICE: Single use adaptor biopsy valve (04953170181009)

GUDID

Device Identifier (DI) Information

Brand Name: Single use adaptor biopsy valve
Version or Model: MAJ-1414
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N1775730
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170181009
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: MAJ-1414 SINGLE USE ADPATER BIOPSY VALV

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):	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?
62145	Endoscopic biopsy valve, single-use	A device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FCG	Biopsy needle

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: 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: bd412766-b3ba-4ffc-bcf1-6c594b1a9cb4
Public Version Date: December 22, 2023
Public Version Number: 5
DI Record Publish Date: September 21, 2016