EG1™ High Speed System XL-HD-G1

GUDID 00845384016526

20.2 cm Heavy Duty X-Long Attachment, G1

Anspach Effort, The

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Primary Device ID00845384016526
NIH Device Record Key48e46ab7-790e-4f70-b1ff-a1f0e02a5827
Commercial Distribution StatusIn Commercial Distribution
Brand NameEG1™ High Speed System
Version Model NumberXL-HD-G1
Catalog NumberXL-HD-G1
Company DUNS079116867
Company NameAnspach Effort, The
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com
Phone+1(800)327-6887
Emailra-dpyus-csvincomfax@its.jnj.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100845384016526 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


[00845384016526]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-13
Device Publish Date2021-05-05

Devices Manufactured by Anspach Effort, The

00845384018759 - EG1™2022-07-18 Wireless Hand Control, EG1A
00845384018766 - EG1™2022-07-18 Receiver for Wireless Hand Control, EG1A
00845384016526 - EG1™ High Speed System2021-05-1320.2 cm Heavy Duty X-Long Attachment, G1
00845384016526 - EG1™ High Speed System2021-05-13 20.2 cm Heavy Duty X-Long Attachment, G1
00845384018520 - KINCISE™2020-05-06 KINCISE AUTOMATED SURGICAL IMPACTOR
00845384018537 - KINCISE™2020-05-06 KINCISE RECHARGEABLE LI-ION BATTERY
00845384018544 - KINCISE™2020-05-06 KINCISE 4-PORT BATTERY CHARGER
00845384018551 - KINCISE™2020-05-06 KINCISE POSTERIOR BROACH ADAPTER
00845384018568 - KINCISE™2020-05-06 KINCISE ANTERIOR BROACH ADAPTER

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