AccessGUDID - DEVICE: EQ-S (08809455600573)

GUDID

Device Identifier (DI) Information

Brand Name: EQ-S
Version or Model: 126-230
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: META SYSTEMS CO., LTD.

Primary DI Number: 08809455600573
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687503532 *Terms of Use

Device Description: EQ-S TIP 15/02

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?
45501	Root canal irrigation handpiece	A hand-operated, air-powered, dental instrument used for the irrigation of prepared root canals to provide thorough debridement of the canal space. It is connected to an air supply via a pressure hose to activate its internal pump mechanism which injects a root canal cleanser via a thin disposable needle into the canal space. This device replaces time consuming manual syringe irrigation and is used for the elimination of pulpal tissue, necrotic materials, and bacteria from the instrumented root canal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JET	Pick, Massaging

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: 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: e68df98d-2889-435b-bf2e-c6c76d61d179
Public Version Date: March 10, 2020
Public Version Number: 1
DI Record Publish Date: March 02, 2020

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

Customer Contact

[?]

No Customer Contact currently defined

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