DEVICE: JOBST Elvarex Plus (04059993700806)

Device Identifier (DI) Information

JOBST Elvarex Plus
79541-00020-00
In Commercial Distribution
79541-00020-00
BSN-Jobst GmbH
04059993700806
GS1

1
315917492 *Terms of Use
ELVAREX PLUS 2/GLOVE/WITH FINGER, WITH THUMB/BEIGE
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Device Characteristics

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

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
16500 Compression/pressure glove
A device in the form of a short or long glove intended to tightly fit over the hand(s) to apply compression/pressure (i.e., graduated or even-force), typically to control oedema, swelling and/or scarring due to arthritis or injuries, and/or to manage lymphoedema; it is not a strip/roll binder, shirt or tubular support bandage. It is typically made of cotton or synthetic elastic material (e.g., Lycra and Spandex) and may be available with openings for fingers and/or with integrated sleeves that may reach the wrist, elbow, or axilla; it does not include antimicrobial features. This is a reusable device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
DWL Stocking, medical support (to prevent pooling of blood in legs)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K123561 000
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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

[?]
Size Type Text
Device Size Text, specify: Pressure 23-32 mmHg
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Device Record Status

5883a6f0-e210-4497-845a-10ef3c6be33f
January 19, 2024
2
November 18, 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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
+1(800)537-1063
HMS.ORDERS@ESSITY.COM
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