AccessGUDID - DEVICE: GRADIC Port Film Graticule, Siemens Compatible (B365540450)

GUDID

Device Identifier (DI) Information

Brand Name: GRADIC Port Film Graticule, Siemens Compatible
Version or Model: 54-045
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Aktina Corp.

Primary DI Number: B365540450
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 787178920 *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:	No
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?
42303	X-ray film ruler	A device used in radiology to superimpose accurate measurements of length (i.e., inches or millimetres) onto an x-ray film so that these measurements remain as a permanent feature of that x-ray against the anatomical structure that has been captured. It is made of x-ray translucent material (e.g., plastic) whilst the graduations are not translucent and therefore show on the exposed x-ray film. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWE	Monitor, Patient Position, Light-Beam

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: ecbadeb7-3132-4957-af9a-c02f238bb18c
Public Version Date: May 31, 2021
Public Version Number: 1
DI Record Publish Date: May 21, 2021

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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