AccessGUDID - DEVICE: Novo Surgical Inc. (00842331190032)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical Inc.
Version or Model: 9123-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9123-02
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331190032
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: flat caps, gas or steam permeable, can be used in flash or conventional autoclave processes, latex-free, 100 per package, 5/8" x 1" x 2", clear w/ vents

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:	Yes
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?
34004	Surgical instrument guard, reusable	A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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: a13ae77f-ecb0-4c2f-9a4e-6961d2185cf7
Public Version Date: December 22, 2022
Public Version Number: 1
DI Record Publish Date: December 14, 2022