AccessGUDID - DEVICE: BUR BUTLER (E2358225TSBC0)

GUDID

Device Identifier (DI) Information

Brand Name: BUR BUTLER
Version or Model: 8225TSBC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8225TSBC
Company Name: SHOFU DENTAL CORPORATION

Primary DI Number: E2358225TSBC0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054618202 *Terms of Use

Device Description: BUR BUTLER 25-HOLE (TALL)

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?
40599	Instrument storage cabinet	A furniture-like device designed for general-purpose use, typically where surgery is practised and carried out, to store and possibly display surgical instruments and other devices/products which will be used during surgical examinations/procedures. It will typically consist of double doors with glass windows in them that close off the shelving, and multiple drawers where the instruments are kept. It can be made of stainless steel, plastic materials, glass and wood. This device will typically be used in operating and procedure rooms, including dental, ophthalmological clinics, and doctors surgeries.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DZP	INSTRUMENT, DIAMOND, DENTAL

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: 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: 46e9efe5-8a41-40bb-9944-d23f44f8beef
Public Version Date: February 11, 2021
Public Version Number: 1
DI Record Publish Date: February 03, 2021

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

Customer Contact

[?]

Phone: +1(800)827-5262
Email: customer-service@shofu.com

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