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Strauss Surgical

FDA UDI

Class II (US FDA UDI)

by American Medical Endoscopy

Identity

Trade Name
Strauss Surgical FDA UDI
Generic Name
Rigid optical ureterorenoscope FDA UDI
Model / Reference
STS-6060-310HA FDA UDI

Identifiers

Primary DI / UDI-DI
00851925007250 FDA UDI
510(k) Number
K992527 FDA UDI
FDA Product Code
FGB FDA UDI
GMDN Term
Rigid optical ureterorenoscope FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 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

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Rigid optical ureterorenoscope

Strauss Surgical by American Medical Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical ureterorenoscope.

Cleared under the same submission

K992527 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
American Medical Endoscopy

Sources (1)

  • FDA UDI 3299550b-04e0-48a8-bccf-b7cdebcbf4c7 33 fields · synced May 31, 2026