AccessGUDID - DEVICE: Quantum (D8255045000000)

GUDID

Device Identifier (DI) Information

Brand Name: Quantum
Version or Model: 504-500-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 504-000-000
Company Name: QUANTUM BIOENGINEERING LTD.

Primary DI Number: D8255045000000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 797604456 *Terms of Use

Device Description: Res-Q Analog

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
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?
61642	Dental implant analog	A device intended to be used as a copy of a dental implant, for a dental laboratory working model, to duplicate the location and restorative platform orientation of the final dental implant; it is not intended for intraoral use. It is a rod-like device made of metal [e.g., titanium (Ti)]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHA	ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 2 Millimeter
Outer Diameter: 2 Millimeter

Device Record Status

Public Device Record Key: b9e4d19f-d845-4783-bb53-2f97757f2cd7
Public Version Date: November 18, 2024
Public Version Number: 3
DI Record Publish Date: April 12, 2018

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(954)474-2556
Email: info@quantumimplants.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES