DEVICE: Rat Tooth Grasper w/Ratchet, 44cm, Disposable (B354OS445RTGR0)
Device Identifier (DI) Information
Rat Tooth Grasper w/Ratchet, 44cm, Disposable
OS445RTGR
Not in Commercial Distribution
ORANGE SURGICAL INSTRUMENTS, LLC
OS445RTGR
Not in Commercial Distribution
ORANGE SURGICAL INSTRUMENTS, LLC
Rat Tooth Grasper w/Ratchet, 44cm, Disposable
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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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? |
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61875 | Endoscopic electrosurgical electrode, monopolar, single-use |
A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GEI | Electrosurgical, Cutting & Coagulation & Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K101733 | 000 |
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
ce5e12cd-e682-41ce-adc8-0edaefa258be
January 01, 2024
7
November 14, 2016
January 01, 2024
7
November 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 |
---|---|---|---|---|---|
B354OS445RTGR10 | 10 | B354OS445RTGR0 | 2019-11-14 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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