Aquaplast PS™ PS-1678

GUDID 10841962118337

Ivory, 1/16" Martin Mandibular Stent

Qfix

External nasal splint
Primary Device ID10841962118337
NIH Device Record Keyadc2e5b0-c53b-4287-b2ac-12af605fa820
Commercial Distribution StatusIn Commercial Distribution
Brand NameAquaplast PS™
Version Model NumberPS-1678
Catalog NumberPS-1678
Company DUNS808875397
Company NameQfix
Device Count3
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
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
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

Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch
Depth0.063 Inch

Device Identifiers

Device Issuing AgencyDevice ID
GS110841962118320 [Primary]
GS110841962118337 [Unit of Use]

FDA Product Code

EPPSPLINT, NASAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-28
Device Publish Date2021-12-20

On-Brand Devices [Aquaplast PS™]

10841962118696Nasal Splint Kit with 3/32" Large Silver Splint
10841962118689Ivory, 3/32" Large " Silver" Splints, pkg. of 10
10841962118665Nasal Kit with 3/32" Small Ivory Silver Splint
10841962118658Ivory, 3/32" Small Silver Splints, pkg. of 10
10841962118634Ivory, 3/32", 12" x 18" sheet
10841962118627Ivory, 3/32", 18" x 24" sheet
10841962118610Ivory, 3/32" Trapezoidal nasal splint, pkg. of 10
10841962118597Ivory, 3/32", 9" x 12" sheet
10841962118580Ivory, 3/32", Tie Down Dressings, 6" x 9" sheet
10841962118566Ivory, 3/32" Large Dr. Silver's Stents
10841962118559Ivory, 3/32" Small, Dr. Silver's Stents Extended Length, Silver Style Stent
10841962118542Ivory, 3/32", 3" x 3" Nasal Splint Blanks
10841962118528Ivory, 3/32", 3 x 3" Nasal Splint Blanks
10841962118504Nasal Splint Kit with 3/32" Ivory 3" x 3" Blank
10841962118498Ivory, 1/16" Small Dr. Silver's Stent
10841962118481Nasal Kit with Ivory 1/16" Large Silver splint
10841962118474Ivory, 1/16" Large Silver splint, pkg. of 10
10841962118450Nasal Kit w/ Ivory 1/16" Small Silver Splint
10841962118443Ivory,1/16" Small Silver splint, pkg. of 10
10841962118429Ivory, 1/16" - 3" x 3" Nasal Splint Blanks
10841962118405Ivory, 1/16", 3" x 3" Nasal Splint Blanks
10841962118382Ivory, 1/16", 6" x 18" sheet
10841962118375Nasal Splint Kit with 1/16" Ivory 3" x 3" Blank
10841962118368Ivory, 1/16", 9" x 12" sheet
10841962118351Ivory, 1/16", 12" x 18" sheet
10841962118344Ivory, 1/16", 18" x 24" sheet
10841962118337Ivory, 1/16" Martin Mandibular Stent
10841962118313Ivory, 1/16" Trapezoidal nasal splint, pkg. of 10
10841962118290Ivory, 1/16" Tie Down Dressings, 6" x 9" sheet
10841962118276Ivory, 1/16", 6" x 18" sheet, Solid
10841962118269Blush, 1/16", 12" x 18" sheet
10841962118252Blush, 1/16", 9" x 12" sheet
10841962118245Blush, 1/16", 18" x 24" sheet
10841962118238Blush, 3/32", 18" x 24" sheet
10841962118221Blush, 3/32", 3 x 3" Nasal Splint Blanks
10841962118207Blush, 1/16", Trapezoidal Nasal Splints
10841962118191Blush, 1/16", Trapezoidal Nasal Splint, pkg. of 10
10841962118177Blush, 1/16" Large Silver splint, pkg. of 10
10841962118153Blush, 1/16" Small Silver splint, pkg. of 10
10841962118139Blush, 1/16" - 3" x 3" Nasal Splint Blanks
10841962107980Nasal Splint Kit with 3/32" Large Silver Splint
10841962107966Ivory, 3/32" Large " Silver" Splints, pkg. of 10
10841962107959Nasal Kit with 3/32" Small Ivory Silver Splint
10841962107935Ivory, 3/32" Small Silver Splints, pkg. of 10
10841962107928Ivory, 3/32", 12" x 18" sheet
10841962107911Ivory, 3/32", 18" x 24" sheet
10841962107898Ivory, 3/32" Trapezoidal nasal splint, pkg. of 10
10841962107881Ivory, 3/32", 9" x 12" sheet
10841962107867Ivory, 3/32", Tie Down Dressings, 6" x 9" sheet
10841962107843Ivory, 3/32" Large Dr. Silver's Stents
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.