AccessGUDID - DEVICE: FlexiProp Reusable Mouth Prop 2 PK Large (00723896020265)

GUDID

Device Identifier (DI) Information

Brand Name: FlexiProp Reusable Mouth Prop 2 PK Large
Version or Model: 7158910 L
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7158910 L
Company Name: PRACTICON, INC.

Primary DI Number: 00723896020265
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Reusable supportive mouth prop to keep patients mouth open. Ridged Bite Channels and floss eyelets ensure safety. 2 pack. Large size

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):	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?
16197	Mouth gag, non-adjustable	A mechanical device without adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral surgical intervention. It is designed to be inserted between the teeth to force the jaws apart and may be in the form of a wedge block, wedge screw, or sprung wedge. Depending on the design it may also be referred to as a jaw spreader, oral wood screw, or mouth prop. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BRW	Protector, Dental

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: 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: 7b566bed-848c-48e6-98ee-928fe1ffe303
Public Version Date: June 16, 2023
Public Version Number: 1
DI Record Publish Date: June 08, 2023