NA - TRANSPOSAL ULTRAFLEX DUO/QUAD ULTRA CART MANIFOLD - ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.

Duns Number:137354267

Device Description: TRANSPOSAL ULTRAFLEX DUO/QUAD ULTRA CART MANIFOLD

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More Product Details

Catalog Number

UL-CL500

Brand Name

NA

Version/Model Number

ULCL500

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

-

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

GCY

Product Code Name

APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Device Record Status

Public Device Record Key

3176c6bf-9baf-47cb-8061-4f7e1781d7bd

Public Version Date

July 15, 2019

Public Version Number

3

DI Record Publish Date

September 27, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1447
2 A medical device with a moderate to high risk that requires special controls. 96