DEVICE: SureClip (06932503530163)
Device Identifier (DI) Information
SureClip
ROCC-D-26-270-C
In Commercial Distribution
ROCC-D-26-270-C
Micro-Tech (Nanjing) Co., Ltd.
ROCC-D-26-270-C
In Commercial Distribution
ROCC-D-26-270-C
Micro-Tech (Nanjing) Co., Ltd.
Open width11±1mm the max OD of insertion part 2.6mm working length 2700mm coated
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PKL | Hemostatic Metal Clip For The Gi Tract |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K152001 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
10b28e6b-82b6-44a1-af5c-7e2173e4b4bc
July 06, 2018
3
March 10, 2016
July 06, 2018
3
March 10, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
26932503530167 | 10 | 16932503530160 | In Commercial Distribution | case | |
16932503530160 | 10 | 06932503530163 | In Commercial Distribution | box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined