Plester retractor - 3 prongs left, blade right, dismountable13.5 cm - Spiggle & Theis Medizintechnik GmbH

Duns Number:332893028

Device Description: 3 prongs left, blade right, dismountable13.5 cm

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More Product Details

Catalog Number

10-427-13

Brand Name

Plester retractor

Version/Model Number

10-427-13

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

GAD

Product Code Name

RETRACTOR

Device Record Status

Public Device Record Key

260357fd-6186-48d4-bf55-e837e2d48c4f

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

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