DEVICE: Action® (00089904000194)

Device Identifier (DI) Information

Action®
Bolx II
In Commercial Distribution
32402
ACTION PRODUCTS, INC.
00089904000194
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© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
58022 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.
Active false
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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 [?]
K811528 000
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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

4ef4d179-a8f8-4371-b657-9112d36d0937
March 24, 2021
3
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

[?]
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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