AccessGUDID - DEVICE: Novo Surgical (G586N96847650)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: N96847-65
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N96847-65
Company Name: NOVO SURGICAL, INC.

Primary DI Number: G586N96847650
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: zenith penfield dissector, #4, single-ended, 8-1/2" (21.5 cm)

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35335	Dura mater dissector	A hand-held surgical instrument, usually softly rounded and curved at the working end, used to separate the outermost membrane covering of the brain and spinal cord from the inner membranes. It is usually designed with a handle which continues into a shaft that terminates at the distal end with a rounded curved tip, or it can be double-ended. It is made of high-grade stainless steel, comes in various shapes and sizes. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDI	DISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ddb8a5c9-04b2-45ac-b922-61001038c549
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)860-6686
Email: info@novosurgical.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES