NA - OP-LARYNGOSCOPE WL 148MM by Steiner adjustable, - Richard Wolf GmbH

Duns Number:315304071

Device Description: OP-LARYNGOSCOPE WL 148MM by Steiner adjustable, dilation prox. min. / max. 32x12.5/ 32x27 OP-LARYNGOSCOPE WL 148MM by Steiner adjustable, dilation prox. min. / max. 32x12.5/ 32x27.5mm, dilation dist. min. / max. 16x13.5/ 16x53mm, TL 200mm, straight blade, outer light carrier and insufflation-suction tube, with universal handle for all support and mounting systems, reusable

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More Product Details

Catalog Number

8456.01

Brand Name

NA

Version/Model Number

845601

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"

-

For Single-Use

-

Prescription Use (Rx)

-

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

CCW

Product Code Name

LARYNGOSCOPE, RIGID

Device Record Status

Public Device Record Key

123e8146-0f3b-4514-a467-232089ba4912

Public Version Date

February 21, 2022

Public Version Number

1

DI Record Publish Date

February 11, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RICHARD WOLF GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 587
2 A medical device with a moderate to high risk that requires special controls. 1835