AccessGUDID - DEVICE: PHOSPHOR PLATE BARRIER ENVELOPES (D89260705533652)

GUDID

Device Identifier (DI) Information

Brand Name: PHOSPHOR PLATE BARRIER ENVELOPES
Version or Model: 6070553365
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: MAXILL, INC.

Primary DI Number: D89260705533652
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10000
Labeler D-U-N-S® Number*: 079343581 *Terms of Use

Device Description: No description.

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?
44823	Digital imaging cassette	A device intended to be used in diagnostic x-ray imaging to hold and shield a phosphor plate (not included) from exposure to room light during transport and insertion into a computed radiography (CR) scanner to produce a digital image of a patient radiation pattern. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PEM	Dental Barriers And Sleeves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163447	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: d59b2cc9-6bb3-424b-af57-a99c75b71fb0
Public Version Date: June 19, 2024
Public Version Number: 2
DI Record Publish Date: July 22, 2022

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: D89260705533650 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

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