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Breeze Nasal Airway SP-79300

by Summit Medical, LLC

Ref SP-79400

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number03856410497_INTSPLINTSLP Basic UDI-DI 00385640064699UDI-DIDate26 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00385640064699 UDI-DI Date9 Aug 2016ListedStatusListed GUDID: 1 of 2 UDI-DIs in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Breeze EUDAMED
Breeze Nasal Airway GUDID
Summit Medical GUDID
Generic Name
Intranasal splint, non-biodegradable
Device Name
Internal Nasal Splints
Model / Ref / Catalog
SP-79400, SP-79300
Primary DI / UDI-DI
00385640064699, 00385640000130
Basic UDI-DI
03856410497_INTSPLINTSLP
FDA Product Code
LYA
EMDN Code
P020203 Nasal splints
GMDN Term
Intranasal splint, non-biodegradable
Device Class
Class I
Regulation Number
874.4780
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution (UDI-DI 00385640000130)
In Commercial Distribution (UDI-DI 00385640064699)

Other devices from Summit Medical, LLC

See all devices from Summit Medical, LLC →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No