AccessGUDID - DEVICE: Olympus (15019778003603)

GUDID

Device Identifier (DI) Information

Brand Name: Olympus
Version or Model: MAJ-1632
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KEYMED (MEDICAL & INDUSTRIAL EQUIPMENT) LIMITED

Primary DI Number: 15019778003603
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 217061423 *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?
17595	Intubation teeth protector	A sterile curved device designed to fit over the upper and lower sets of teeth to protect them from damage during endotracheal (ET) tube intubation procedures. Such protection can be required when the patient is resisting the intubation by clenching their teeth which can be damaged against the metal or plastic blade of the intubation laryngoscope, and/or if the patient has bad teeth that are liable to inadvertent damage, and/or if this is normal hospital procedure to counter liability claims. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNK	Endoscopic Bite Block

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: No
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: de89b5aa-ea37-4e5f-b98a-95526c3b368c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 19, 2016