DEVICE: PROCARE (00190446154914)

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Device Record History
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Device Identifier (DI) Information
PROCARE
79-84007-0213
In Commercial Distribution

DJO, LLC
00190446154914
GS1

1
081840873 *Terms of Use
DELUXE ARM SLING (L), HEALTH CARE EXP
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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?
12095 Arm immobilizer
A non-rigid device, usually made of a fabric, used to temporarily render the arm immovable, typically at the shoulder and elbow, to support healing of an injury or a surgical wound. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
ILI SLING, ARM
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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
936b2fe6-7426-4cfd-9ada-5b99a3776f9d
October 06, 2023
1
September 28, 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
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)

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

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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