Catalog Number

1001-77B

Brand Name

Scanlan® SURG-I-LOOP® silicone loops

Version/Model Number

1001-77B

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

GAE

Product Code Name

Snare, Surgical

Public Device Record Key

30397a20-4359-4197-979c-213d8750a434

Public Version Date

May 06, 2020

Public Version Number

2

DI Record Publish Date

December 12, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-