AccessGUDID - DEVICE: Olympus (04042761008778)

GUDID

Device Identifier (DI) Information

Brand Name: Olympus
Version or Model: A5797
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: A5797
Company Name: OLYMPUS Winter & Ibe GmbH

Primary DI Number: 04042761008778
Issuing Agency: GS1
Commercial Distribution End Date: July 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 316957240 *Terms of Use

Device Description: Suction/irrigation tube, 10 mm, for A5796

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?
61793	Endoscopic suction valve, reusable	A non-sterile device intended to be fitted to an endoscope suction channel to enable the operator to control suction whist preventing inflow of air. It is in the form of an attachable valve that controls (opens/closes) the suction channel. 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 [?]
K923982	000
K944200	000
K944201	000

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: 256a0e2b-7b29-4a68-a7bd-df20a0cbfc9f
Public Version Date: July 16, 2021
Public Version Number: 5
DI Record Publish Date: September 22, 2016