DEVICE: Action® (00089904000125)

Device Identifier (DI) Information

Action®
Bolx I
In Commercial Distribution
31202
ACTION PRODUCTS, INC.
00089904000125
GS1

1
067543058 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Radiation therapy bolus, reusable A pliable, solid, non-sterile material (e.g., firm gel, paraffin, silicone) that has the properties of skin when irradiated and is intended to be applied to the skin to modify radiation dose at the skin surface or depth. It is available in various static thicknesses (e.g., 0.5 to 4.0 cm), which may be cut by the operator, to provide a reproducible radiation beam modifier for a prescribed dose depth during treatment of a particular site and disease. This is a reusable device.
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FDA Product Code

[?]
Product Code Product Code Name
JAD System, Therapeutic, X-Ray
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Store flat
Special Storage Condition, Specify: Store in a clean, dry environment
Special Storage Condition, Specify: Minimal UV light exposure
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

0362590b-88f9-4add-b25c-cd3d61dd53fb
March 29, 2018
2
November 21, 2016
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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
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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