Sphero Flex 0828615

GUDID 00842092181751

Sphero Flex Abutment Calcitek Integral 3.25 x 4mm (2.5mm Ball)

Preat Corporation

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Primary Device ID00842092181751
NIH Device Record Key74762250-e918-4a70-a6a4-a12c85f817f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSphero Flex
Version Model Number0828615
Catalog Number0828615
Company DUNS117776048
Company NamePreat Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com
Phone+1 (800) 232-7732
Emailinfo@preat.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100842092181751 [Primary]

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


[00842092181751]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-27
Device Publish Date2023-09-19

On-Brand Devices [Sphero Flex]

00842092165195Sphero Flex Abutment Nobel Active/Conical NP x 1mm
00842092181430Sphero Flex Abutment Branemark RP x 2mm
00842092181423Sphero Flex Abutment Branemark RP x 1mm
00842092181768Sphero Flex Abutment Calcitek Integral 3.25 x 2mm (2.5mm Ball)
00842092181751Sphero Flex Abutment Calcitek Integral 3.25 x 4mm (2.5mm Ball)

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