NA - COMBINED SPINAL EPIDURAL TRAYEpiSpin Lock Tuohy - PAJUNK MEDICAL SYSTEMS, LP

Duns Number:136718553

Device Description: COMBINED SPINAL EPIDURAL TRAYEpiSpin Lock Tuohy Epidural Needle 17G x 3.5“ withSPROTTE® Sp COMBINED SPINAL EPIDURAL TRAYEpiSpin Lock Tuohy Epidural Needle 17G x 3.5“ withSPROTTE® Spinal Needle 25G and EpiLong Soft Catheter, Closed Tip, 19G0.75% Bupivacaine HCl with 8.25% Dextrose

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More Product Details

Catalog Number

NA

Brand Name

NA

Version/Model Number

TCL101

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OFT

Product Code Name

Spinal Epidural Anesthesia Kit

Device Record Status

Public Device Record Key

e5bfae70-f2e5-45d9-a2f2-6dc3c4fed7b8

Public Version Date

November 11, 2019

Public Version Number

1

DI Record Publish Date

November 01, 2019

Additional Identifiers

Package DI Number

20858965006087

Quantity per Package

10

Contains DI Package

00858965006083

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PAJUNK MEDICAL SYSTEMS, LP" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 41