DEVICE: NA (06932503533089)

Device Identifier (DI) Information

NA
IN12-196232002
In Commercial Distribution
IN12-196232002
Micro-Tech (Nanjing) Co., Ltd.
06932503533089
GS1

1
530269083 *Terms of Use
POM inner tuber,Needle Length 6mm,with metal cap 19G*6*2.3*200,Shroat stucture
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Submucosal injection needle A sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomical structures with lumens. This is a single-use device.
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FDA Product Code

[?]
Product Code Product Code Name
FBK Endoscopic Injection Needle, Gastroenterology-Urology
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K150434 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

6f084f26-4ca2-4488-9391-bfd05ed69c28
July 06, 2018
3
March 10, 2016
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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
26932503533083 10 16932503533086 In Commercial Distribution case
16932503533086 10 06932503533089 In Commercial Distribution box
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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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