ZeroWire G2 - DePuy Synthes, ZeroWire G2 Receiver Only - Nds Surgical Imaging LLC

Duns Number:081712583

Device Description: DePuy Synthes, ZeroWire G2 Receiver Only

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More Product Details

Catalog Number

-

Brand Name

ZeroWire G2

Version/Model Number

90T2111

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)

-

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

GCJ

Product Code Name

Laparoscope, General & Plastic Surgery

Device Record Status

Public Device Record Key

3dc8174b-a694-40fa-8560-dde2b5f2cad0

Public Version Date

March 03, 2022

Public Version Number

4

DI Record Publish Date

October 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NDS SURGICAL IMAGING LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 194
2 A medical device with a moderate to high risk that requires special controls. 147