AccessGUDID - DEVICE: First Medica (D822LB002)

GUDID

Device Identifier (DI) Information

Brand Name: First Medica
Version or Model: LB002
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: USA THINK INC.

Primary DI Number: D822LB002
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 026643854 *Terms of Use

Device Description: Slim Blast dental curing light

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?
35761	Dental laboratory curing unit	A mains electricity (AC-powered) device used in the dental laboratory for curing polymer-based materials. This can be achieved by heat, heat and pressure, light, or a combination of these. For a curing light used chairside see the appropriate GMDN code.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBZ	Activator, Ultraviolet, For Polymerization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K040956	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: 672fa497-33b7-4c78-b74c-d005b8ab6c2e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: November 23, 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: 6057877717
Email: information@firstmedica.com

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