General Purpose Rectal/Esophageal Probe, Medium, Schiller

FDA UDI

Class II (US FDA UDI)

by Sensatronic GmbH

Identity

Trade Name: General Purpose Rectal/Esophageal Probe, Medium, Schiller FDA UDI
Generic Name: General-purpose patient temperature probe, reusable FDA UDI
Device Name: Reusable temperature probe, rectal/esophageal, medium, Schiller AG branded FDA UDI
Model / Reference: PR-500S1 FDA UDI
Description: Reusable temperature probe, rectal/esophageal, medium, Schiller AG branded FDA UDI

Identifiers

Catalog Number: 2.101106 FDA UDI
Primary DI / UDI-DI: 04260651380302 FDA UDI
510(k) Number: K203643 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: General-purpose patient temperature probe, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 5.0 Meter FDA UDI

Category: General-purpose patient temperature probe, reusable

A General Purpose Rectal/Esophageal Probe, Medium, Schiller AG is a reusable temperature sensing device designed for general use. This temperature probe is ideal for medical professionals and patients alike, offering accurate measurements of body temperatures in various locations.

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Cleared under the same submission

K203643 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Sensatronic GmbH

Sources (1)

FDA UDI 5437b025-25f4-4a21-ac75-7f61b2327684 37 fields · synced Jul 13, 2026

General Purpose Rectal/Esophageal Probe, Medium, Schiller

Identity

Identifiers

Classification

Clinical & Handling

Dimensions & Sizes

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)