AccessGUDID - DEVICE: Ti-Max X (04560264510906)

GUDID

Device Identifier (DI) Information

Brand Name: Ti-Max X
Version or Model: X55
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: NAKANISHI INC.

Primary DI Number: 04560264510906
Issuing Agency: GS1
Commercial Distribution End Date: February 15, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 690710546 *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:	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?
45574	Dental power tool converter attachment, non-rotary	A dental attachment, commonly known as a ratchet adaptor, drive converter, or dental turbine, designed to be fitted in a dental power tool handpiece to convert energy (e.g., electrical, pneumatic) to a sagittal, oscillating or reciprocating mechanical motion to achieve a specific function (e.g., sawing) during dental procedures [e.g., maxillofacial surgery]. It is not an endpiece; an appropriate interchangeable endpiece (e.g., saw blade) is intended to be fixed to the working end of this device. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EGS	Handpiece, contra- and right-angle attachment, dental

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: 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: 5f18a8c3-227e-41ef-82f6-f25db32f97d3
Public Version Date: February 15, 2021
Public Version Number: 3
DI Record Publish Date: June 05, 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: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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