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Aquaplast PS™
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref PS-1771Model Aquaplast PS Thermoplastics
by Qfix
Identity
- Trade Name
- Aquaplast PS™ FDA UDI
- Generic Name
- External nasal splint FDA UDI
- Device Name
- Ivory, 3/32", Tie Down Dressings, 6" x 9" sheet FDA UDI
- Model / Reference
- PS-1771 EUDAMEDFDA UDIAquaplast PS Thermoplastics EUDAMED
- Description
- Ivory, 3/32", Tie Down Dressings, 6" x 9" sheet FDA UDI
Identifiers
- Catalog Number
- PS-1771 FDA UDI
- Primary DI / UDI-DI
- 10841962118573 EUDAMEDFDA UDI
- Basic UDI-DI
- 8419621PSTHERMOMQ EUDAMED
- FDA Product Code
- EPP FDA UDI
- EMDN Code
- P020203 NASAL SPLINTS EUDAMED
- GMDN Term
- External nasal splint FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.5800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Depth — 0.094 Inch FDA UDILength — 6 Inch FDA UDIWidth — 9 Inch FDA UDI
Category: External nasal splint
Aquaplast PS™ by Qfix — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as External nasal splint.
- ENTPROMED — ENTPROMED SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
- External aluminium nasal splint — Spiggle & Theis Medizintechnik GmbH · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
- BRIDGEMASTER™ — MEDTRONIC XOMED, INC. · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
- Equipment box for external nasal splints — Spiggle & Theis Medizintechnik GmbH · Class I
- DENVER SPLINT — Summit Medical, LLC · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Qfix
Sources (2)
- FDA UDI 846622ce-45d9-4f88-a1ee-183ef4c9c9c8 36 fields · synced Jul 11, 2026
- EUDAMED 1fa82b09-8f47-4c79-ade0-e19dac025c3e 61 fields · synced Jul 11, 2026