AccessGUDID - DEVICE: Velcro Strap For Prism (B525ST030)

GUDID

Device Identifier (DI) Information

Brand Name: Velcro Strap For Prism
Version or Model: ST-03
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Octostop Inc

Primary DI Number: B525ST030
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 240536946 *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?
37692	X-ray/radiation therapy beam filter, wedge	A wedge-shaped metal filter placed in a beam of primary radiation before it reaches the patient undergoing radiation therapy or imaging procedure. In radiation therapy it ensures uniform irradiation of body areas that vary in thickness or density. In diagnostic imaging it is used to obtain films of a more uniform density when the part being examined diminishes greatly in thickness from one side of the field to the other. It is typically made from aluminium (Al), lead (Pb), copper (Cu), tin (Sn) or combinations of these. Also called compensation filter because when one side of a patient is considerably thicker/denser than the other, the wedge compensates for the physical difference.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPR	System, x-ray, stationary

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: 5b5c22fe-3e29-4b26-a5e2-4f8e0444c41a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 16, 2017

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: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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