DEVICE: Triumph (10818634022650)

Device Identifier (DI) Information

Triumph
71-ME2360
Not in Commercial Distribution
71-ME2360
Bosma Enterprises
10818634022650
GS1
March 31, 2024
50
878070325 *Terms of Use
Triumph Micro Latex Surgical 6.0 - 50 Pair/Box
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
No
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?
47178 Hevea-latex surgical glove, non-powdered, non-antimicrobial
A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against contamination from microorganisms. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KGO Surgeon'S Gloves
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Protect from freezing, avoid excessive heat. Keep dry. Shield from direct sunlight, fluorescent lighting, x-rays, moisture, and ozone.
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 6.0
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Device Record Status

debbfab7-a441-449d-9a67-9cac88428e90
April 01, 2024
3
July 01, 2021
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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
20818634022657 4 10818634022650 2024-03-31 Not 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: 00818634022653 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-362-5463
kimm@bosma.org
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