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Thompson

FDA UDI

Class II (US FDA UDI)

by Thompson Surgical Instruments

Identity

Trade Name
Thompson FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
Case - PLA Onestep Dilator FDA UDI
Model / Reference
50000PLAO FDA UDI
Description
Case - PLA Onestep Dilator FDA UDI

Identifiers

Primary DI / UDI-DI
00841536103939 FDA UDI
510(k) Number
K151347 FDA UDI
FDA Product Code
KCT FDA UDI
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.6850 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

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Thompson by Thompson Surgical Instruments — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151347 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thompson Surgical Instruments

Sources (1)

  • FDA UDI e82e06ab-764c-4cd1-aa55-7d528e767aab 35 fields · synced May 31, 2026