Novo Surgical - Dolphin Nose Forceps - Disposable Sheath & Tip - NOVO SURGICAL, INC.

Duns Number:033029433

Device Description: Dolphin Nose Forceps - Disposable Sheath & Tip System, box of 10 disposable inserts (sheat Dolphin Nose Forceps - Disposable Sheath & Tip System, box of 10 disposable inserts (sheath & tip), 5.0 mm sheath diameter, short version, double action, working length 13" (33.0 cm)

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More Product Details

Catalog Number

9000-27153DST

Brand Name

Novo Surgical

Version/Model Number

9000-27153DST

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

K974382,K974382

Product Code Details

Product Code

GCJ

Product Code Name

Laparoscope, general & plastic surgery

Device Record Status

Public Device Record Key

5defbbb3-cae5-457b-bbca-9595549d6fa5

Public Version Date

August 21, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"NOVO SURGICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 2724