Imaging Extension, Long, OPERON D 750-D 8000099

GUDID 10841962110492

Imaging Extension, Long, OPERON D 750-D

Qfix

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Primary Device ID10841962110492
NIH Device Record Key48823b1d-81ad-44ab-a597-1c3bb84b4f0d
Commercial Distribution StatusIn Commercial Distribution
Brand NameImaging Extension, Long, OPERON D 750-D
Version Model Number8000099
Catalog Number8000099
Company DUNS808875397
Company NameQfix
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 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(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com
Phone+1(610)268-0585
EmailCompliance@qfix.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch
Device Size Text, specify0
Device Size Text, specify0
Length44 Inch
Width21 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS110841962110492 [Primary]

FDA Product Code

KXJTable, radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-12-11
Device Publish Date2017-05-26

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10841962107423 - Aquaplast PS™2023-12-11 Blush, 1/16" Large Silver splint, pkg. of 10
10841962107447 - Aquaplast PS™2023-12-11 Blush, 1/16" Tie Down Dressings, 6" x 9" sheet
10841962107461 - Aquaplast PS™2023-12-11 Blush, 1/16", Trapezoidal Nasal Splint, pkg. of 10
10841962107485 - Aquaplast PS™2023-12-11 Blush, 1/16", Trapezoidal Nasal Splints
10841962107492 - Aquaplast PS™2023-12-11 Blush, 3/32", 3 x 3" Nasal Splint Blanks
10841962107515 - Aquaplast PS™2023-12-11 Blush, 3/32", 18" x 24" sheet
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