Aquaplast PS™

FDA UDI

Class I (US FDA UDI)

by Qfix

Identity

Trade Name: Aquaplast PS™ FDA UDI
Generic Name: External nasal splint FDA UDI
Device Name: Blush, 1/16" Tie Down Dressings, 6" x 9" sheet FDA UDI
Model / Reference: PS-1307 FDA UDI
Description: Blush, 1/16" Tie Down Dressings, 6" x 9" sheet FDA UDI

Identifiers

Catalog Number: PS-1307 FDA UDI
Primary DI / UDI-DI: 10841962107447 FDA UDI
FDA Product Code: EPP FDA UDI
GMDN Term: External nasal splint FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 874.5800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Dimensions & Sizes

Size: Width — 9 Inch FDA UDI
Length — 6 Inch FDA UDI
Depth — 0.063 Inch FDA UDI

Category: External nasal splint

Aquaplast PS™ by Qfix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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DENVER SPLINT — Summit Medical, LLC · Class I
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DENVER SPLINT — Summit Medical, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Qfix

Sources (1)

FDA UDI 86e2c2c4-9761-4399-bb8a-4f3fae414fb9 36 fields · synced May 30, 2026