FDA.report

Safco Mouth Props

Primary DI
D72310297670
Brand
Safco Mouth Props
Company
SAFCO DENTAL SUPPLY CO.
Model
1029767
Catalog number
1029767
Device description
Safco silicone mouth props, adult, large, 2/box
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
BRWProtector, dental

Product Code Classifications

CodeDeviceSpecialtyClass
BRWProtector, DentalAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D72310297673PrimaryHIBCC0
D72310297670Unit of UseHIBCC0

GMDN Terms

TermDefinition
Mouth gag, non-adjustableA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
020417380
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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