DEVICE: CARDINAL HEALTH (10885380066580)

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Device Record History
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Device Identifier (DI) Information
CARDINAL HEALTH
SCL812
In Commercial Distribution
SCL812
Cardinal Health 200, LLC
10885380066580
GS1

1
961027315 *Terms of Use
Silicone Contact Layer 8 x 12in. Dressing
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
Yes
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?
36226 Cavity-wound management dressing, non-antimicrobial
A non-bioabsorbable material or substance designed to be inserted into a wound bed to create an appropriate environment for healing (e.g., warm, moist, absorbent); it does not include an antimicrobial agent(s). It is typically used for the management of deep secondary-healing wounds, particularly for indications such as stage III and IV pressure ulcers, deep leg ulcers, cavity wounds, excisions, and post-op wound dehiscence. It is often designed to conform to the wound bed to support tissues and is often nonadherent to provide for patient comfort during wound management. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
NAD Dressing, wound, occlusive
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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
Storage Environment Temperature: between 0 and 35 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
d47120c4-9b3e-4447-96f6-3de95830b1ba
September 23, 2024
5
May 30, 2019
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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
00888499001322 5 10885380066580 In Commercial Distribution BOX
10888499001329 5 00888499001322 In Commercial Distribution CASE
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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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