AccessGUDID - DEVICE: 9mm Nozzle With Nozzle Extruder (15060238201718)

GUDID

Device Identifier (DI) Information

Brand Name: 9mm Nozzle With Nozzle Extruder
Version or Model: N700
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N700
Company Name: SUMMIT MEDICAL LIMITED

Primary DI Number: 15060238201718
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 221751311 *Terms of Use

Device Description: 9mm Nozzle With Nozzle Extruder

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?
47737	Orthopaedic cement injection cannula	A sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIH	Dispenser, Cement

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 4 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 12026179-67f0-4669-a9f8-8bb5a7fe796f
Public Version Date: January 20, 2025
Public Version Number: 1
DI Record Publish Date: January 10, 2025