DEVICE: Single Use Rotatable Clip Fixing Device (04953170353130)
Device Identifier (DI) Information
Single Use Rotatable Clip Fixing Device
HX-201LR-135L
In Commercial Distribution
N4541130
OLYMPUS MEDICAL SYSTEMS CORP.
HX-201LR-135L
In Commercial Distribution
N4541130
OLYMPUS MEDICAL SYSTEMS CORP.
Single Use Rotatable Clip Fixing Device
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
35649 | Ligation clip, metallic |
A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MND | Ligator, esophageal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1460a34c-925e-4984-83f0-ffdcc4d90ae4
August 30, 2023
5
September 21, 2016
August 30, 2023
5
September 21, 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 |
---|---|---|---|---|---|
14953170353137 | 20 | 04953170353130 | In Commercial Distribution | ||
54953170353135 | 4 | 14953170353137 | 2023-08-29 | Not in Commercial Distribution |
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
[?]
+1(800)401-1086
xx@xx.xx
xx@xx.xx