SCANLAN® Miscellaneous Instruments - STERN CHEST TUBE PASSER WITH RATCHET 14" 35.6CM - SCANLAN INTERNATIONAL INC

Duns Number:023055619

Device Description: STERN CHEST TUBE PASSER WITH RATCHET 14" 35.6CM

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More Product Details

Catalog Number

4004-190

Brand Name

SCANLAN® Miscellaneous Instruments

Version/Model Number

4004-190

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

DWS

Product Code Name

Instruments, Surgical, Cardiovascular

Device Record Status

Public Device Record Key

5e75c4b8-56ed-42d2-83c6-01cf98827531

Public Version Date

November 18, 2019

Public Version Number

1

DI Record Publish Date

November 08, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SCANLAN INTERNATIONAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1949
2 A medical device with a moderate to high risk that requires special controls. 855