AccessGUDID - DEVICE: SCHICK (D764B63030001)

GUDID

Device Identifier (DI) Information

Brand Name: SCHICK
Version or Model: B6303000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIRONA DENTAL, INC.

Primary DI Number: D764B63030001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078613913 *Terms of Use

Device Description: USBCAM KIT (CAMERA; HOLDER; 25 SHEATHS; DRIVER CD)

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:	Yes
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?
40983	Diagnostic-imaging photographic film, self-developing	A self-developing photographic film (e.g., instant or Polaroid) specifically designed for use in a dedicated camera and used for medical or dental imaging applications; especially where it is advantageous to see if the image captured reflects the best possible or intended view of the actual situation of the moment. It is typically designed with specific archival properties that determine the useful life of images captured on the medium.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, Operative Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K963778	000

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: 4ee72b82-4001-46a2-a8ef-2cecce5e92fc
Public Version Date: December 09, 2022
Public Version Number: 4
DI Record Publish Date: September 09, 2016

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

[?]

Phone: (877) 724-4254
Email: customerserviceny@sirona.com

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