SABLE - Doctor's Package

GUDID 00841359060082

SABLE E-Type Doctor's Package. Package contains: Air Motor(1600110), 1:1 Contra Angle(1600211), 1:1 Nosecone(1600310)

Sable Industries Inc

Dental power tool handpiece motorless component
Primary Device ID00841359060082
NIH Device Record Key8f3a752b-8bd7-4b06-95fe-2839b35ec8da
Commercial Distribution StatusIn Commercial Distribution
Brand NameSABLE - Doctor's Package
Version Model Number1600016
Company DUNS255407272
Company NameSable Industries Inc
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com
Phone1-800-368-8106
Emailinfo@sableindustriesinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841359060082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EGSHandpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


[00841359060082]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-08
Device Publish Date2022-07-29