Pediatric Table, OPERON D 750-D 850 (US) 8002074

GUDID 10841962110461

Pediatric Table, OPERON D 750-D 850 (US)

Qfix

Universal operating table top

• Primary Device ID: 10841962110461
• NIH Device Record Key: 0106f829-aa66-41a2-bf65-ca741b1f961e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pediatric Table, OPERON D 750-D 850 (US)
• Version Model Number: 8002074
• Catalog Number: 8002074
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com

Device Dimensions

• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch
• Width: 1.12 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Width: 21 Inch
• Device Size Text, specify: 0
• Length: 36 Inch
• Width: 12.25 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962110461 [Primary]

FDA Product Code

• GDC: TABLE, OPERATING-ROOM, ELECTRICAL

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: 2023-12-11
• Device Publish Date: 2017-05-30

Devices Manufactured by Qfix

• 10841962107386 - Aquaplast PS™: 2023-12-11 Blush, 1/16" - 3" x 3" Nasal Splint Blanks
• 10841962107409 - Aquaplast PS™: 2023-12-11 Blush, 1/16" Small Silver splint, pkg. of 10
• 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