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Sun Medical Inc

FDA UDI

Class II (US FDA UDI)

by Sun Medical, Inc.

Identity

Trade Name
Sun Medical Inc FDA UDI
Generic Name
Surgical fluid/smoke waste management system suction unit FDA UDI
Device Name
Smoke Evacuator Circiut FDA UDI
Model / Reference
8730000 FDA UDI
Description
Smoke Evacuator Circiut FDA UDI

Identifiers

Catalog Number
8730000 FDA UDI
Primary DI / UDI-DI
B22687300001 FDA UDI
510(k) Number
K911154 FDA UDI
FDA Product Code
FYD FDA UDI
GMDN Term
Surgical fluid/smoke waste management system suction unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.5070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Surgical fluid/smoke waste management system suction unit

Sun Medical Inc by Sun Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical fluid/smoke waste management system suction unit.

Cleared under the same submission

K911154 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sun Medical, Inc.

Sources (1)

  • FDA UDI 221386ea-d345-442c-8a46-255bfa6f3502 36 fields · synced May 30, 2026