Single Use Hemoclip

GUDID 16970401815569

Zhejiang Chuangxiang Medical Technology Co., LTD.

Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term Gastrointestinal endoscopic clip, short-term

Primary Device ID	16970401815569
NIH Device Record Key	2c4f2825-d1e6-4c32-b4fb-2d4093f8d577
Commercial Distribution Status	In Commercial Distribution
Brand Name	Single Use Hemoclip
Version Model Number	MD-C-HR-230-13-090-N
Company DUNS	544434963
Company Name	Zhejiang Chuangxiang Medical Technology Co., LTD.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Conditional
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970401814916 [Primary]
GS1	16970401815569 [Package] Contains: 06970401814916 Package: Box [10 Units] In Commercial Distribution
GS1	26970401811872 [Package] Package: Case [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K212669

FDA Product Code

PKL	Hemostatic Metal Clip For The Gi Tract

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2022-08-25
Device Publish Date	2022-08-17

On-Brand Devices [Single Use Hemoclip]

16970401815798	MD-S-HR-195-9-135-Y
16970401815361	MD-L-HR-195-15-135-Y
16970401815910	MD-S-HR-165-9-090-N
16970401815897	MD-S-HR-195-9-090-N
16970401815873	MD-S-HR-230-9-090-N
16970401815859	MD-S-HR-270-9-090-N
16970401815828	MD-S-HR-165-9-135-N
16970401815804	MD-S-HR-195-9-135-N
16970401815781	MD-S-HR-230-9-135-N
16970401815767	MD-S-HR-270-9-135-N
16970401815743	MD-G-HR-165-12-090-N
16970401815729	MD-G-HR-195-12-090-N
16970401815705	MD-G-HR-230-12-090-N
16970401815682	MD-G-HR-270-12-090-N
16970401815668	MD-G-HR-165-12-135-N
16970401815637	MD-G-HR-270-12-135-N
16970401815613	MD-C-HR-165-13-090-N
16970401815583	MD-C-HR-195-13-090-N
16970401815569	MD-C-HR-230-13-090-N
16970401815163	MD-C-HR-270-13-090-N
16970401815903	MD-S-HR-165-9-090-Y
16970401815880	MD-S-HR-195-9-090-Y
16970401815866	MD-S-HR-230-9-090-Y
16970401815835	MD-S-HR-270-9-090-Y
16970401815811	MD-S-HR-165-9-135-Y
16970401815774	MD-S-HR-230-9-135-Y
16970401815750	MD-S-HR-270-9-135-Y
16970401815736	MD-G-HR-165-12-090-Y
16970401815712	MD-G-HR-195-12-090-Y
16970401815699	MD-G-HR-230-12-090-Y
16970401815675	MD-G-HR-270-12-090-Y
16970401815590	MD-C-HR-165-13-090-Y
16970401815576	MD-C-HR-195-13-090-Y
16970401815545	MD-C-HR-270-13-090-Y
16970401815538	MD-C-HR-165-13-135-N
16970401815514	MD-C-HR-195-13-135-N
16970401815491	MD-C-HR-230-13-135-N
16970401815484	MD-C-HR-270-13-135-N
16970401815477	MD-L-HR-165-15-090-N
16970401815453	MD-L-HR-195-15-090-N
16970401815439	MD-L-HR-230-15-090-N
16970401815415	MD-L-HR-270-15-090-N
16970401815392	MD-L-HR-165-15-135-N
16970401815378	MD-L-HR-195-15-135-N
16970401815354	MD-L-HR-230-15-135-N
16970401815347	MD-L-HR-270-15-135-N
16970401815330	MD-A-HR-165-16-090-N
16970401815316	MD-A-HR-195-16-090-N
16970401815293	MD-A-HR-230-16-090-N
16970401815279	MD-A-HR-270-16-090-N