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USA Series

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
USA Series FDA UDI
Generic Name
Rigid endoscope telescope FDA UDI
Device Name
USA Series Long Autoclavable Operative Telescope 12 Degrees, 2.7 mm Diameter FDA UDI
Model / Reference
G27L-12A FDA UDI
Description
USA Series Long Autoclavable Operative Telescope 12 Degrees, 2.7 mm Diameter FDA UDI

Identifiers

Primary DI / UDI-DI
00821925008915 FDA UDI
510(k) Number
K980972 FDA UDI
FDA Product Code
HEW FDA UDI
GMDN Term
Rigid endoscope telescope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.1640 FDA UDI
Commercial Distribution
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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Rigid endoscope telescope

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

Similar devices

Also classified as Rigid endoscope telescope.

Cleared under the same submission

K980972 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 79ba0333-8c6a-4934-859b-3b68226c96a3 34 fields · synced May 30, 2026