DEVICE: SureClip (06932503530309)
Device Identifier (DI) Information
SureClip
ROCC-F-26-235-C
In Commercial Distribution
ROCC-F-26-235-C
Micro-Tech (Nanjing) Co., Ltd.
ROCC-F-26-235-C
In Commercial Distribution
ROCC-F-26-235-C
Micro-Tech (Nanjing) Co., Ltd.
Open width16±2mm the max OD of insertion part 2.6mm working length 2350mm 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? |
---|---|---|---|---|
61208 | Gastrointestinal endoscopic clip, long-term, non-bioabsorbable |
A non-bioabsorbable clip intended to be implanted long-term (>30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, treating mucosal/submucosal defects, and/or as part of bariatric procedures. It is a metallic device with a clasping mechanism; a disposable applicator may be included.
|
Active | true |
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
899d6884-ff9c-49d5-a7f1-c350a38e7254
May 13, 2021
4
March 10, 2016
May 13, 2021
4
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 |
---|---|---|---|---|---|
26932503530303 | 10 | 16932503530306 | In Commercial Distribution | case | |
16932503530306 | 10 | 06932503530309 | 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