DEVICE: DeRoyal (00749756350495)

Device Identifier (DI) Information

DeRoyal
NP-6007-01
In Commercial Distribution
NP-6007-01
DEROYAL INDUSTRIES, INC.
00749756350495
GS1

1
096372255 *Terms of Use
NPWT Contour Med MAXX Kit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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?
47956 Negative-pressure wound therapy system dressing set
A collection of devices that composes a sterile dressing pack used with the pump and collection container of a negative pressure wound therapy (NPWT) system to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic) and diabetic/pressure ulcers. It typically includes dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, a drain, an evacuation tube, and sterile saline. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KDD Kit, surgical instrument, disposable
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FDA Premarket Submission

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

Sterilization

Yes
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

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

6b4823ba-0fba-43c7-b0ba-bf4e08b43de5
February 14, 2023
1
February 06, 2023
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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
50749756350490 20 00749756350495 In Commercial Distribution BB
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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