Allrap Protective Barriers

GUDID 00615375004197

XRay Sleeve

METREX RESEARCH, LLC

Instrument/equipment drape, single-use, non-sterile
Primary Device ID00615375004197
NIH Device Record Key38feb7d2-bc7a-4770-8cf8-ab58dd5977ef
Commercial Distribution StatusIn Commercial Distribution
Brand NameAllrap Protective Barriers
Version Model NumberSXRS250C
Company DUNS145963778
Company NameMETREX RESEARCH, LLC
Device Count250
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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+18008411428
Emailcustomercare@kavokerrgroup.com
Phone+18008411428
Emailcustomercare@kavokerrgroup.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100615375004197 [Primary]
GS100615375007204 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EFBHANDPIECE, AIR-POWERED, DENTAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-31

On-Brand Devices [Allrap Protective Barriers]

00615375005118Roll of Perforated Sheets Clear Cover Film
00615375005095Roll of Perforated Sheets Blue Cover Film
00615375004975SlipnGrip Chair Cover
00615375004968SlipnGrip Half Chair Stool Cover
00615375004869SlipnGrip Chair Cover
00615375004234Universal XRay Sleeve
00615375004227Tray Sleeve Cover Large
00615375004210Tray Sleeve Cover Small
00615375004203TStyle Sleeve Lamp Handle Cover
00615375004197XRay Sleeve
00615375004180Syringe Sleeve XL
00615375004173Syringe HVE Valve Sleeve
00615375004166Handpiece Sleeve Straight Slow Speed
00615375004159Handpiece Sleeve Universal Size
00615375004142Headrest Covers Small
00615375004135Headrest Covers Large

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