General Purpose Rectal/Esophageal Probe, Medium, Schiller - Reusable temperature probe, rectal/esophageal, - Sensatronic GmbH

Duns Number:331950332

Device Description: Reusable temperature probe, rectal/esophageal, medium, Schiller AG branded

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More Product Details

Catalog Number

2.101106

Brand Name

General Purpose Rectal/Esophageal Probe, Medium, Schiller

Version/Model Number

PR-500S1

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

5437b025-25f4-4a21-ac75-7f61b2327684

Public Version Date

December 09, 2021

Public Version Number

1

DI Record Publish Date

December 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SENSATRONIC GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 18