Medicon - Pratt rectal speculum 21cm - Medicon eG. Chirurgiemechaniker-Genossenschaft

Duns Number:315492330

Device Description: Pratt rectal speculum 21cm

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More Product Details

Catalog Number

50.73.20

Brand Name

Medicon

Version/Model Number

50.73.20

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

FFQ

Product Code Name

SPECULUM, RECTAL

Device Record Status

Public Device Record Key

8895ba1d-3c7f-49d5-b899-11c80b80301c

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDICON EG. CHIRURGIEMECHANIKER-GENOSSENSCHAFT" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7911
2 A medical device with a moderate to high risk that requires special controls. 1064