AccessGUDID - DEVICE: Henry Schein (H65890042860)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 9004286
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9004286
Company Name: HENRY SCHEIN, INC.

Primary DI Number: H65890042860
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: X-Ray Film HSI Green Sensitive

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?
16937	Photographic paper	A device prepared from thin sheet of fibrous material that has been specially produced for recording the output of an image in the form of a photograph. Different methods for reproducing the images upon the paper may be utilized. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWZ	Film, radiographic

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: 0a6f2e11-9beb-4758-869d-b2f8c0230878
Public Version Date: June 17, 2020
Public Version Number: 1
DI Record Publish Date: June 09, 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
H65890042861	5	H65890042860		In Commercial Distribution

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: H65890042869 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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