AccessGUDID - DEVICE: Nobilium (M482D1EN0)

GUDID

Device Identifier (DI) Information

Brand Name: Nobilium
Version or Model: D1EN
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CMP INDUSTRIES LLC

Primary DI Number: M482D1EN0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002064319 *Terms of Use

Device Description: DENTURE ID MICROCHIP DENTURE ID MICROCHIP

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
60472	Radio-frequency identification patient positioning/tracking system	An assembly of hardware/software devices intended to employ radio-frequency identification (RFID) techniques to aid in the correct identification and positioning of the patient during a diagnostic imaging, treatment planning or radiation therapy procedure. It typically consists of RFID tags worn by the patient or embedded/attached to treatment accessories, a RFID reader, optical markers and optical camera, monitor, and hand-held control unit; it may also use an infrared tracking camera and/or a video camera.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PYQ	Rfid Chip For Dental Appliance

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170423	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: e2c2fbf7-bdc5-44ab-98f3-721f425b32bd
Public Version Date: July 06, 2018
Public Version Number: 2
DI Record Publish Date: May 16, 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

[?]

No Customer Contact currently defined

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

FDA TOOLS & RESOURCES