Summit Medical

FDA UDI

Class U (US FDA UDI)

by Summit Medical, LLC

Identity

Trade Name: SUMMIT MEDICAL FDA UDI
Generic Name: Intranasal splint, non-biodegradable FDA UDI
Model / Reference: SP-78105 FDA UDI

Identifiers

Catalog Number: SP-78100 FDA UDI
Primary DI / UDI-DI: 00385640065214 FDA UDI
510(k) Number: K982667 FDA UDI
FDA Product Code: LFB FDA UDI
GMDN Term: Intranasal splint, non-biodegradable FDA UDI

Classification

Device Class: U FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Intranasal splint, non-biodegradable

Summit Medical by Summit Medical, LLC — Class U — FDA UDI — listed in FDA GUDID — 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

Cleared under the same submission

K982667 also covers:

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 U	Pending data

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Manufacturer

Manufacturer: Summit Medical, LLC

Sources (1)

FDA UDI 63262fed-e724-4158-aabe-7a26d2b3b101 35 fields · synced May 31, 2026