FDA.reportPublic FDA data

Zyris

Primary DI
10810032661127
Brand
Zyris
Company
ZYRIS, INC.
Model
CAM0403
Catalog number
CAM0403
Device description
Anterior Mouthpiece, 100-Pack, Pediatric
Published
2024-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIFACCESSORIES, RETRACTOR, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810032661120PrimaryGS10
10810032661127Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810032661120008100326611208100326611200810032661120
1081003266112710810032661127

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction protective mouthpieceA prefabricated device designed to be placed in the oral cavity during a dental procedure to protect the oral pathway by serving as a conduit for the continuous suction of debris/saliva, shielding the oral anatomy, maintaining an open mouth and retracted cheeks, and depressing the tongue. It is made of preformed materials for direct insertion into the mouth and includes features for connection to a dental suction unit. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)560-6066regulatory@zyris.com

Regulatory Flags#

DUNS number
068038277
Device count
100
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810032660765Isolite, i3PIL0301PIL03012024-04-19
00810032660772Isolite, i3PIL0302PIL03022024-04-19
00810032660789Isolite, i3PIL0304PIL03042024-04-19
00810032660796Isolite, i3PIL0305PIL03052024-04-19
00810032660802Isolite, i3PIL0306PIL03062024-04-19
00810032660819Isolite, i3PIL0307PIL03072024-04-19
00810032660826Isolite, i3PIL0308PIL03082024-04-19
00810032660833Isolite, i3PIL0309PIL03092024-04-19
00810032660840Isolite, i3PIL0311PIL03112024-04-19
00810032660857Isolite, i3PIL0312PIL03122024-04-19
00810032660864Isolite, i3PIL0313PIL03132024-04-19
00810032660871Isolite, i3PIL0314PIL03142024-04-19
00810032660888Isolite, i3PIL0315PIL03152024-04-19
00810032660901Isolite, i3PIL0318PIL03182024-04-19
00810032660925Isolite, i3PIL0320PIL03202024-04-19
00810032660932Isolite, i3PIL0321PIL03212024-04-19
00810032660956Isolite, i3PIL0323PIL03232024-04-19
00810032660963Isolite, i3PIL0324PIL03242024-04-19
00810032660444Isolite, i3EIL0308EIL03082024-04-08
00810032660918Isolite, i3PIL0319PIL03192024-04-08

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