Allrap Protective Barriers

GUDID 00615375005095

Roll of Perforated Sheets Blue Cover Film

METREX RESEARCH, LLC

Instrument/equipment drape, single-use, non-sterile

• Primary Device ID: 00615375005095
• NIH Device Record Key: 1ae0cc1a-2066-4325-92dd-5b0d0f051f0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allrap Protective Barriers
• Version Model Number: 460BC
• Company DUNS: 145963778
• Company Name: METREX RESEARCH, LLC
• Device Count: 1200
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18008411428
• Email: customercare@kavokerrgroup.com
• Phone: +18008411428
• Email: customercare@kavokerrgroup.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00615375005095 [Primary]
GS1	00615375007778 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960352

FDA Product Code

• EFB: HANDPIECE, AIR-POWERED, DENTAL

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-31

On-Brand Devices [Allrap Protective Barriers]

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