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SlimLine

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
SlimLine FDA UDI
Generic Name
Endoscope sheath, reusable FDA UDI
Device Name
SlimLine Continuous Flow Operative Hysteroscope Visual Kit FDA UDI
Model / Reference
GY275L-VK FDA UDI
Description
SlimLine Continuous Flow Operative Hysteroscope Visual Kit FDA UDI

Identifiers

Primary DI / UDI-DI
00821925001848 FDA UDI
510(k) Number
K890328 FDA UDI
FDA Product Code
HIH FDA UDI
GMDN Term
Endoscope sheath, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1690 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

SlimLine by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K890328 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI 388395b6-e8f0-408d-8cad-34f9ee304780 35 fields · synced Jun 1, 2026