AccessGUDID - DEVICE: Premium Plus (D83817802)

GUDID

Device Identifier (DI) Information

Brand Name: Premium Plus
Version or Model: 178-0
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Premium Plus International Limited

Primary DI Number: D83817802
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 668367758 *Terms of Use

Device Description: Protective Paper Covers

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:	Yes
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?
17102	X-ray film storage envelope	A thick paper envelope configured to form a flat container/holder specifically designed for the storage and transport of images recorded on x-ray film. It is usually of a size to contain sheet film (35 x 43 cm), but is also available in sizes designed to accommodate specialized x-ray film formats, e.g., those used in chiropractic, paediatric or mammography imaging applications.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NRD	Unit, Operative Dental, Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 7a7de515-0a59-4e1e-86b0-273455eabe1f
Public Version Date: January 16, 2020
Public Version Number: 1
DI Record Publish Date: January 08, 2020

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: D83817800 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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

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