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Parapella I, SI, 1.14 mm

EUDAMEDFDA UDI

Class IIb (EU MDR)

Ref VT-0300-01

by Summit Medical, LLC

Identity

Trade Name
Parapella I, SI, 1.14 mm EUDAMED
NA FDA UDI
Generic Name
Tympanostomy tube FDA UDI
Device Name
Otological Ventilation Tubes EUDAMED
Model / Reference
VT-0300-01 EUDAMEDFDA UDI

Identifiers

Primary DI / UDI-DI
00385640000994 EUDAMEDFDA UDI
Basic UDI-DI
B-00385640000994 EUDAMED
510(k) Number
K830228 FDA UDI
FDA Product Code
ETD FDA UDI
EMDN Code
Q03040199 EAR DRAINAGE AND VENTILATION DEVICES - OTHER EUDAMED
GMDN Term
Tympanostomy tube FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
874.3880 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Conditional FDA UDI

Parapella I, SI, 1.14 mm by Summit Medical, LLC — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Summit Medical, LLC
EUDAMED SRN
US-MF-000026771
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (2)

  • EUDAMED 7af887f5-a25b-4689-a96d-8aabc2be7463 61 fields · synced Jul 9, 2026
  • FDA UDI bf1c8cd3-4617-4508-9d9f-cf6427be341d 35 fields · synced May 27, 2026