FDA UDI In Commercial Distribution 🇺🇸 United States

FlexiProp Reusable Mouth Prop 2 PK Large

DI: 00723896020265 · Model: 7158910 L · PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
FlexiProp Reusable Mouth Prop 2 PK Large
Primary DI
00723896020265
Version / Model
7158910 L
Catalog Number
7158910 L
Company Name
PRACTICON, INC.
Labeler DUNS
119193803
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-06-08
Public Version
1
Public Version Date
2023-06-16
Public Version Status
New
Public Device Record Key
7b566bed-848c-48e6-98ee-928fe1ffe303

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

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
BRW Protector, Dental

GMDN Terms

Code Name
16197 Mouth gag, non-adjustable

Identifiers

Type ID
Package 00723896020272
Primary 00723896020265