AccessGUDID - DEVICE: Applicator (07290016746723)

GUDID

Device Identifier (DI) Information

Brand Name: Applicator
Version or Model: MM01000-AG2.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MM01000-AG2.0
Company Name: VIORA LTD

Primary DI Number: 07290016746723
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 514612758 *Terms of Use

Device Description: EnerJet Applicator

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?
42949	Needleless medication/vaccine injector, pneumatic	A hand-held, pneumatically-powered device designed to inject medication (especially a local anaesthetic) or vaccine transcutaneously into the human body. It is needleless and may have various configurations according to its application. It will typically be a pistol-shaped plunger driven instrument with single or multi-pointed holed barrels through which the medication/vaccine is driven under high pressure by compressed gas. The delivered medication/vaccine will typically be supplied in prefilled containers that are loaded into the device. This is not a hypodermic syringe. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KZE	Injector, Fluid, Non-Electrically Powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 80d2ffd7-2557-4efb-9219-af0ea1ad88bb
Public Version Date: May 30, 2025
Public Version Number: 1
DI Record Publish Date: May 22, 2025

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: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 888 415 1192
Email: CustomerCareUsa@sinclair.com

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