AccessGUDID - DEVICE: RALLY All In One Cement Gun (08031497002330)

GUDID

Device Identifier (DI) Information

Brand Name: RALLY All In One Cement Gun
Version or Model: 71271610
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TECRES SPA

Primary DI Number: 08031497002330
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435428396 *Terms of Use

Device Description: RALLY ALL IN ONE CEMENT GUN is intended to be used for helping the extrusion (and hence the delivery) of the bone cement prepared with the RALLY ALL IN ONE SYSTEM devices.

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):	No
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?
47703	Orthopaedic cement/bone filler dispensing gun	A hand-operated device designed to hold an orthopaedic cement/filler syringe/cartridge and to facilitate the dispensing of the substance to the application site or an application device. It is a pistol-like device with a barrel recess, to place the syringe/cartridge, which includes a trigger mechanism to force the substance from the distal end, and may include graduated markings to dispense the substance in discrete quantities. This is a reusable 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: 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: 33be2c13-832b-41fd-b023-e402a1990287
Public Version Date: October 03, 2022
Public Version Number: 1
DI Record Publish Date: September 23, 2022