Scanlan® SUTURE BOOT™ Instrument Jaw Covers - Scanlan® SUTURE BOOT™ Instrument Jaw Covers - - SCANLAN INTERNATIONAL INC

Duns Number:023055619

Device Description: Scanlan® SUTURE BOOT™ Instrument Jaw Covers - Original Yellow, BNS (1000 per bag)

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More Product Details

Catalog Number

1001-514BX

Brand Name

Scanlan® SUTURE BOOT™ Instrument Jaw Covers

Version/Model Number

1001-514BX

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

Yes

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

KDC

Product Code Name

Instrument, Surgical, Disposable

Device Record Status

Public Device Record Key

951dba5b-e3a9-4156-b105-1c721708795e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 28, 2017

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