Synergetics - Universal Soft Tip - SYNERGETICS USA, INC.

Duns Number:021056726

Device Description: Universal Soft Tip

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More Product Details

Catalog Number

30.10

Brand Name

Synergetics

Version/Model Number

30.10

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

251f8787-fd61-4912-b999-01a42859f892

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Additional Identifiers

Package DI Number

20841305107926

Quantity per Package

6

Contains DI Package

10841305101446

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"SYNERGETICS USA, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 336
2 A medical device with a moderate to high risk that requires special controls. 47