Pearson PL551B 4-0 Plain Gut Suture w/ C6 Needle - PEARSON DENTAL SUPPLIES, INC.

Duns Number:082874108

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More Product Details

Catalog Number

-

Brand Name

Pearson PL551B 4-0 Plain Gut Suture w/ C6 Needle

Version/Model Number

L540606

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

GAL

Product Code Name

Suture, Absorbable, Natural

Device Record Status

Public Device Record Key

c071e207-727f-411e-8904-abca98ca07c2

Public Version Date

February 05, 2021

Public Version Number

3

DI Record Publish Date

June 29, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PEARSON DENTAL SUPPLIES, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 447