Parkell® - Compression Cap Non-Anatomic Assortment (150 pcs) - PARKELL, INC.

Duns Number:009900424

Device Description: Compression Cap Non-Anatomic Assortment (150 pcs)

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More Product Details

Catalog Number

S196A

Brand Name

Parkell®

Version/Model Number

S196A

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

EFN

Product Code Name

Cotton, Roll

Device Record Status

Public Device Record Key

47309faf-d221-4485-9260-2989dd414404

Public Version Date

August 11, 2022

Public Version Number

2

DI Record Publish Date

July 26, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARKELL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 476
U Unclassified 19