AccessGUDID - DEVICE: DiamondTOUCH™ Syringe (00884450833964)

GUDID

Device Identifier (DI) Information

Brand Name: DiamondTOUCH™ Syringe
Version or Model: A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IN9VCF
Company Name: Merit Medical Systems, Inc.

Primary DI Number: 00884450833964
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 184763290 *Terms of Use

Device Description: No description.

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:	Yes
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?
35809	Orthopaedic cement dispenser	A syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAR	Injector, vertebroplasty (does not contain 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c38cf4b0-d395-4465-9f06-aa1fa0b04faa
Public Version Date: November 25, 2024
Public Version Number: 1
DI Record Publish Date: November 16, 2024