PILLING - SPONGE BRONCHOSCOPIC GAUZE STERILE 1/4X3/4" 200/ - TELEFLEX INCORPORATED

Duns Number:002348191

Device Description: SPONGE BRONCHOSCOPIC GAUZE STERILE 1/4X3/4" 200/ BOX

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More Product Details

Catalog Number

200240

Brand Name

PILLING

Version/Model Number

IPN004261

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

K913302,K913302,K913302

Product Code Details

Product Code

GDY

Product Code Name

GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Device Record Status

Public Device Record Key

8919a76f-f5bd-4270-a58b-348eedd305f9

Public Version Date

October 16, 2018

Public Version Number

1

DI Record Publish Date

September 15, 2018

Additional Identifiers

Package DI Number

24026704417760

Quantity per Package

20

Contains DI Package

04026704417766

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"TELEFLEX INCORPORATED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3195
2 A medical device with a moderate to high risk that requires special controls. 13747
3 A medical device with high risk that requires premarket approval 3
U Unclassified 26