Graspit - Nitinol Stone Retrieval Forceps - BOSTON SCIENTIFIC CORPORATION

Duns Number:021717889

Device Description: Nitinol Stone Retrieval Forceps

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More Product Details

Catalog Number

-

Brand Name

Graspit

Version/Model Number

M0063204000

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

FFL

Product Code Name

DISLODGER, STONE, BASKET, URETERAL, METAL

Device Record Status

Public Device Record Key

d825aec2-33e1-44a6-a1b4-fff09f372f5d

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BOSTON SCIENTIFIC CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 536
2 A medical device with a moderate to high risk that requires special controls. 8659
3 A medical device with high risk that requires premarket approval 1821
U Unclassified 35