AccessGUDID - DEVICE: Henry Schein (00304040062012)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 5700691
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5700691
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040062012
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: MaxPro Highspeed Handpiece

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?
43698	Dental power tool system, pneumatic	An assembly of devices designed to bore and excavate bones, teeth, and tough tissues during a dental surgical procedure. It typically consists of a motorized drill handpiece and/or motor, a control unit, and a variety of attachments used to hold the drilling/excavating instruments (e.g., drill bits, burs, polishing disks). This system is pneumatically-powered (gas-powered), normally by compressed air via a connecting hose to the handpiece/motor. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EFB	Handpiece, air-powered, 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: 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: 6e1fdc33-06bf-44f9-8334-0b726f676947
Public Version Date: November 11, 2019
Public Version Number: 5
DI Record Publish Date: October 16, 2017

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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