AccessGUDID - DEVICE: Adapter Siemens (J021026920001)

GUDID

Device Identifier (DI) Information

Brand Name: Adapter Siemens
Version or Model: 02692000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: W & H Dentalwerk Bürmoos GmbH

Primary DI Number: J021026920001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 300238441 *Terms of Use

Device Description: Adapter for Assistan

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?
60447	Surgical power tool maintenance adaptor	A device intended to connect a surgical power tool (e.g., pneumatically or electrically driven motors, turbines, or attachments) to a maintenance device (i.e., maintenance unit or lubricant container) during maintenance/lubrication of the surgical power tool. It is typically a metal attachment designed to connect a specific type of tool and maintenance device together.	Active	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: 22fd5ddd-f769-4f69-9d2f-cff71caa5f92
Public Version Date: July 19, 2023
Public Version Number: 1
DI Record Publish Date: July 11, 2023

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

[?]

No Customer Contact currently defined

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