AccessGUDID - DEVICE: Inoris Medical Sp. z o.o. (05902596226121)

GUDID

Device Identifier (DI) Information

Brand Name: Inoris Medical Sp. z o.o.
Version or Model: IM-20 Clip-on Biteguard
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INORIS MEDICAL SP Z O O

Primary DI Number: 05902596226121
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 522725233 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
10405	Seizure bite block	A non-sterile device inserted into a patient's mouth for the prevention of oral tissue damage (e.g., the teeth, lips, tongue and buccal mucosa) typically when the patient has convulsions (a seizure) or is undergoing an electroconvulsive therapy (ECT) that will cause nausea or can cause him/her to bite their jaws together. It will also secure a free flow for air and vomit. 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: No 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: ccd60f4f-08c1-4c9f-9b8d-2c3f13a6d2c8
Public Version Date: August 17, 2020
Public Version Number: 1
DI Record Publish Date: August 07, 2020