AccessGUDID - DEVICE: WATER CONTAINER (CAP AND TUBE) (04953170025563)

GUDID

Device Identifier (DI) Information

Brand Name: WATER CONTAINER (CAP AND TUBE)
Version or Model: MA-995
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170025563
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: GX9538 WATER CONT. W/CLIP & O RING

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?
61156	Endoscopic irrigation/distension bottle	A device intended to be used during endoscopy procedures to provide a receptacle for irrigation water and a conduit for air/carbon dioxide (CO2) used for insufflation. It is typically in the form of an empty plastic bottle with a connector intended to attach to the proximal end of an endoscope and/or to a gas supply. 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 [?]
High-level Disinfectant
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: fff971ae-ec77-447a-ad15-74073c66ed00
Public Version Date: January 16, 2023
Public Version Number: 7
DI Record Publish Date: September 21, 2016