Laryngeal mirror, rhodium coated - with fixed hexagonal handle, size 9 28 mm - Spiggle & Theis Medizintechnik GmbH

Duns Number:332893028

Device Description: with fixed hexagonal handle, size 9 28 mm

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More Product Details

Catalog Number

40-525-09

Brand Name

Laryngeal mirror, rhodium coated

Version/Model Number

40-525-09

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

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

LRC

Product Code Name

INSTRUMENT, ENT MANUAL SURGICAL

Device Record Status

Public Device Record Key

3f1129bd-6ffa-4906-a8a3-8f2e9dbbd4eb

Public Version Date

February 17, 2021

Public Version Number

1

DI Record Publish Date

February 09, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SPIGGLE & THEIS MEDIZINTECHNIK GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1960
2 A medical device with a moderate to high risk that requires special controls. 97