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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
Hand-held endoscopic retractor, reusable FDA UDI
Model / Reference
STS-LAP-105-53 FDA UDI

Identifiers

Primary DI / UDI-DI
00810143890402 FDA UDI
510(k) Number
K060233 FDA UDI
FDA Product Code
GCJ FDA UDI
GMDN Term
Hand-held endoscopic retractor, reusable 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

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

Category: Hand-held endoscopic retractor, reusable

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

Similar devices

Also classified as Hand-held endoscopic retractor, reusable.

Cleared under the same submission

K060233 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 89f8404a-7341-46ae-8791-bc56da845872 33 fields · synced May 30, 2026