Aquaplast PS™ PS-1309CSS

GUDID 00841962120319

Blush, 1/16", Trapezoidal Splint, pkg. of 10 - CSS

Qfix

External nasal splint

• Primary Device ID: 00841962120319
• NIH Device Record Key: 0b04f9a8-b150-4d5a-a13e-2683fdfdf528
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aquaplast PS™
• Version Model Number: PS-1309CSS
• Catalog Number: PS-1309CSS
• Company DUNS: 808875397
• Company Name: Qfix
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• 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: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com
• Phone: 800-842-8688
• Email: regulatory@cqmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841962120319 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942158

FDA Product Code

• EPP: Splint, Nasal

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-17
• Device Publish Date: 2025-07-09

On-Brand Devices [Aquaplast PS™]

• 10841962118696: Nasal Splint Kit with 3/32" Large Silver Splint
• 10841962118689: Ivory, 3/32" Large " Silver" Splints, pkg. of 10
• 10841962118665: Nasal Kit with 3/32" Small Ivory Silver Splint
• 10841962118658: Ivory, 3/32" Small Silver Splints, pkg. of 10
• 10841962118634: Ivory, 3/32", 12" x 18" sheet
• 10841962118627: Ivory, 3/32", 18" x 24" sheet
• 10841962118610: Ivory, 3/32" Trapezoidal nasal splint, pkg. of 10
• 10841962118597: Ivory, 3/32", 9" x 12" sheet
• 10841962118580: Ivory, 3/32", Tie Down Dressings, 6" x 9" sheet
• 10841962118566: Ivory, 3/32" Large Dr. Silver's Stents
• 10841962118559: Ivory, 3/32" Small, Dr. Silver's Stents Extended Length, Silver Style Stent
• 10841962118542: Ivory, 3/32", 3" x 3" Nasal Splint Blanks
• 10841962118528: Ivory, 3/32", 3 x 3" Nasal Splint Blanks
• 10841962118504: Nasal Splint Kit with 3/32" Ivory 3" x 3" Blank
• 10841962118498: Ivory, 1/16" Small Dr. Silver's Stent
• 10841962118481: Nasal Kit with Ivory 1/16" Large Silver splint
• 10841962118474: Ivory, 1/16" Large Silver splint, pkg. of 10
• 10841962118450: Nasal Kit w/ Ivory 1/16" Small Silver Splint
• 10841962118443: Ivory,1/16" Small Silver splint, pkg. of 10
• 10841962118429: Ivory, 1/16" - 3" x 3" Nasal Splint Blanks
• 10841962118405: Ivory, 1/16", 3" x 3" Nasal Splint Blanks
• 10841962118382: Ivory, 1/16", 6" x 18" sheet
• 10841962118375: Nasal Splint Kit with 1/16" Ivory 3" x 3" Blank
• 10841962118368: Ivory, 1/16", 9" x 12" sheet
• 10841962118351: Ivory, 1/16", 12" x 18" sheet
• 10841962118344: Ivory, 1/16", 18" x 24" sheet
• 10841962118337: Ivory, 1/16" Martin Mandibular Stent
• 10841962118313: Ivory, 1/16" Trapezoidal nasal splint, pkg. of 10
• 10841962118290: Ivory, 1/16" Tie Down Dressings, 6" x 9" sheet
• 10841962118276: Ivory, 1/16", 6" x 18" sheet, Solid
• 10841962118269: Blush, 1/16", 12" x 18" sheet
• 10841962118252: Blush, 1/16", 9" x 12" sheet
• 10841962118245: Blush, 1/16", 18" x 24" sheet
• 10841962118238: Blush, 3/32", 18" x 24" sheet
• 10841962118221: Blush, 3/32", 3 x 3" Nasal Splint Blanks
• 10841962118207: Blush, 1/16", Trapezoidal Nasal Splints
• 10841962118191: Blush, 1/16", Trapezoidal Nasal Splint, pkg. of 10
• 10841962118177: Blush, 1/16" Large Silver splint, pkg. of 10
• 10841962118153: Blush, 1/16" Small Silver splint, pkg. of 10
• 10841962118139: Blush, 1/16" - 3" x 3" Nasal Splint Blanks
• 10841962107980: Nasal Splint Kit with 3/32" Large Silver Splint
• 10841962107966: Ivory, 3/32" Large " Silver" Splints, pkg. of 10
• 10841962107959: Nasal Kit with 3/32" Small Ivory Silver Splint
• 10841962107935: Ivory, 3/32" Small Silver Splints, pkg. of 10
• 10841962107928: Ivory, 3/32", 12" x 18" sheet
• 10841962107911: Ivory, 3/32", 18" x 24" sheet
• 10841962107898: Ivory, 3/32" Trapezoidal nasal splint, pkg. of 10
• 10841962107881: Ivory, 3/32", 9" x 12" sheet
• 10841962107867: Ivory, 3/32", Tie Down Dressings, 6" x 9" sheet
• 10841962107843: Ivory, 3/32" Large Dr. Silver's Stents