DEVICE: Primeros (19556807313891)

Device Identifier (DI) Information

Primeros
The King 3's
In Commercial Distribution
QA-224
RICHTER RUBBER TECHNOLOGY SDN. BHD.
19556807313891
GS1

3
652647942 *Terms of Use
Natural latex male condom. Transparent, flared shaped, nominal width 57 mm, smooth with reservoir. Lubricated with silicone oil. 100% electronically tested.”
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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?
45138 Basic male condom, Hevea-latex
A Hevea-latex rubber sheath intended to completely cover the penis during coitus to prevent sperm from gaining access to the female reproductive tract and/or prevent the transmission of sexually transmitted infections (STI). It may be textured, flavoured or contain lubricants. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
HIS Condom
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K070511 000
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store in a cool dry place (below 100 F) and avoid exposure to direct sunlight. Avoid excess heat.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9572d045-706f-44ff-b1bf-ea99ab5eb5a9
May 13, 2024
1
May 03, 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
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: 09556807313900 CLOSE

Direct Marking (DM)

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

[?]
Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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