Identity
- Trade Name
- Rhino Rocket Slimline EUDAMEDSUMMIT MEDICAL FDA UDI
- Generic Name
- Intranasal splint, non-biodegradable FDA UDI
- Device Name
- PVA Nasal Packs EUDAMED
- Model / Reference
- 11S-S0500-08AS EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00385640048682 EUDAMEDFDA UDI
- Basic UDI-DI
- 03856490148_PVAPRODSJZ EUDAMED
- FDA Product Code
- LYA FDA UDI
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
- GMDN Term
- Intranasal splint, non-biodegradable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.4780 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intranasal splint, non-biodegradable
Summit Medical by Summit Medical, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Intranasal splint, non-biodegradable.
- Compresses stériles de gaze hydrophile 8cm x 7cm 17 fils/cm2 - 12 plis sachet de 5 compresses — Adhe-Els SA. · Class I
- Intranasl Splint INS — Boston Medical Products, Inc. · Class I
- Sterile Gauze Balls — Kingstar Medical (Xianning) Co., LTD · Class I
- Sterile Absorbent Pads — GS Medical · Class I
- Sterile Gauze Sponges — JIANGSU FEIXIA MEDICAL PRODUCTS CO., LTD · Class I
- Sterile Pad 9cm x 15cm one fold Without X-Ray ETO sterile — ERMED TIP MEDİKAL TİCARET A.Ş. · Class IIa
- Gauze Swabs — Jiujiang HuaDa Medical Dressing Co., Ltd. · Class I
- Custom Nasal Splint — Boston Medical Products, Inc. · 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
- Summit Medical, LLC
Sources (2)
- FDA UDI 0de036f0-9414-4fcf-89a1-bf2db1726c5b 32 fields · synced Jul 21, 2026
- EUDAMED dfc2284e-8551-4998-8a4b-66ca9cb1fd9b 61 fields · synced Jul 21, 2026