DEVICE: HPH Corp. (05391512282912)

Device Identifier (DI) Information

HPH Corp.
648K size 28
In Commercial Distribution
648K
INDACO SRL
05391512282912
GS1

1
338470646 *Terms of Use
The HPH Hernia Brief may help you to live comfortably with a hernia if you don’t desire an operation. Keeps all sizes of hernias in place. Better than any other remedy, medical or not, that is on the market - such as bulky belts or trusses. Easy and comfortable to wear - made from 80% stretchable, Mako cotton and 20% elastane. The cotton assures perspiration-free comfort. No pinching or binding - but gives the highest suspension. Lifts and supports internal organs. The pressure of ordinary hernia belts often causes the hernia to protrude. Only the best materials and highest workmanship have been used. Each HPH Hernia Brief is perfectly constructed with unique and precise stretch zones. Built-in supporting stretch material covering the entire abdominal area. Starting at the bottom, extending to the waist, around the back, lifting and supporting the kidneys. It also gives maximum support to all the internal organs. A soft, stretch fabric with slip opening, keeps the genital area free from pressure. Inner pockets provide for the HPH Disc Cushion to be inserted, giving perfect closing of the inguinal canal, pressure, and suspension. It fits exactly to the body contour. The hernia patient can easily put the HPH Disc Cushion in the correct position himself.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
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. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47218 Abdominal hernia truss, reusable
A device, typically in the form of a strap(s), designed to be worn over an abdominal hernia opening (weakness in the abdominal wall) to prevent protrusion of the abdominal contents and retain the reduced hernia within the abdominal cavity. It may be made from a variety or combination of various materials (e.g., elastic, canvas, or metallic). This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EXN Support, Hernia
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

6559088e-b4d9-42f0-b7d8-1277f44926d2
April 12, 2024
1
April 04, 2024
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-866-888-1331
support@herniabrief.com
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