DEVICE: Oasis (B031AHS70)

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Device Record History
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Device Identifier (DI) Information
Oasis
AHS-7
In Commercial Distribution

American Health Service Sales Corporation
B031AHS70
HIBCC

1
556115970 *Terms of Use
SURGEON GLOVES,LATEX,SIZE 7
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Device Characteristics
Labeling does not contain MRI Safety Information
Yes
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?
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 [?]
K151114 000
No 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
3b596df8-e3d4-4c6a-86c9-4379312b109a
September 18, 2024
1
September 10, 2024
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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
B031AHS71 50 B031AHS70 In Commercial Distribution box
B031AHS72 10 B031AHS71 In Commercial Distribution carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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