AccessGUDID - DEVICE: System B (00889989068412)

GUDID

Device Identifier (DI) Information

Brand Name: System B
Version or Model: 952-0001
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ORMCO CORPORATION

Primary DI Number: 00889989068412
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 154614119 *Terms of Use

Device Description: Heat Source, Model 1005

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?
17890	Endodontic filling material condenser	A dental instrument that uses heat to condense an endodontic filling material in a root canal, in the axial/lateral direction. The working part is typically cylindrical or tapered, and circular in cross-section. A condenser is commonly used to function as a plugger or spreader. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAT	Tester, pulp

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
Special Storage Condition, Specify: Relative Humidity 10% to 95% Atmospheric Pressure: 101.1 Kpa Store between -10 to 45 Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 22848677-4e69-4601-89be-b432ade5b9ef
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 12, 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +18005377123
Email: EndoRotaryCustCare@kerrdental.com

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