DEVICE: NA (06959664911211)

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Device Record History
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Device Identifier (DI) Information
NA
AG-5534-2300-090
In Commercial Distribution

Hangzhou AGS MedTech Co., Ltd.
06959664911211
GS1

1
542984702 *Terms of Use
No description.
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Device Characteristics
MR Conditional
No
Yes
Yes
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?
61207 Gastrointestinal endoscopic clip, short-term
A sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PKL Hemostatic Metal Clip For The Gi Tract
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K172727 000
No CLOSE

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

[?]
Storage and Handling
Storage Environment Temperature: between -10 and 40 Degrees Celsius
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
d42004fa-30e7-4083-b7af-03363f5e67a2
August 06, 2018
1
July 05, 2018
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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
26959664911215 5 16959664911218 In Commercial Distribution
16959664911218 10 06959664911211 In Commercial Distribution
46959664911219 25 36959664911212 In Commercial Distribution
36959664911212 2 06959664911211 In Commercial Distribution
56959664911216 5 06959664911211 In Commercial Distribution
66959664911213 10 56959664911216 In Commercial Distribution
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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
Yes CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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