NA - Sterilisation a. stor. tray f. SUPERFLEX soft - Fehling Instruments GmbH & Co. KG

Duns Number:315028238

Device Description: Sterilisation a. stor. tray f. SUPERFLEX soft tissue retract.

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More Product Details

Catalog Number

MTK-0

Brand Name

NA

Version/Model Number

MTK-0

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)

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

FSM

Product Code Name

Tray, Surgical, Instrument

Device Record Status

Public Device Record Key

8a15264b-df81-42c7-aa8d-2f1c90cb81f8

Public Version Date

September 21, 2022

Public Version Number

1

DI Record Publish Date

September 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FEHLING INSTRUMENTS GMBH & CO. KG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 120
2 A medical device with a moderate to high risk that requires special controls. 349