DEVICE: Medline ReNewal (10888277395398)
Device Identifier (DI) Information
Medline ReNewal
MSREP115781
In Commercial Distribution
MSREP115781
MEDLINE INDUSTRIES, INC.
MSREP115781
In Commercial Distribution
MSREP115781
MEDLINE INDUSTRIES, INC.
EICA4845-01 @COBLATOR II ENT REFLEX ULT
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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? |
---|---|---|---|---|
61817 | Endoscopic electrosurgical handpiece/electrode, bipolar, reprocessed |
A sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a previously used single-use device that has been processed for an additional single-use patient application.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GEI | ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 5.5 Millimeter |
Device Record Status
49719b67-ca1b-410f-8cd2-fb9c2fd847d0
March 29, 2018
2
October 14, 2016
March 29, 2018
2
October 14, 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 |
---|---|---|---|---|---|
No Package DIs found |
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)633-5463
service@medline.com
service@medline.com