DEVICE: Kaydee (06947084921101)

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Device Record History
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Device Identifier (DI) Information
Kaydee
SSK-10W
In Commercial Distribution

Xi'an Kaydee Medical Appliances Co.,Ltd
06947084921101
GS1

1
529128708 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
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?
35884 Skin stapler/staple, non-bioabsorbable
A hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
QQS Stapler, Skin
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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
ab0a7f9c-90b1-4af4-8e6f-98f1f3b5772e
December 09, 2022
2
November 22, 2022
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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
16947084921108 10 06947084921101 In Commercial Distribution Medium packaging
26947084921105 6 06947084921101 In Commercial Distribution Medium packaging
56947084921106 80 06947084921101 In Commercial Distribution Outer packaging
66947084921103 72 06947084921101 In Commercial Distribution Outer packaging
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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
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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