DEVICE: Titanium Grasper (00860012315505)
Device Identifier (DI) Information
Titanium Grasper
200123
In Commercial Distribution
G.I. Windows, Inc.
200123
In Commercial Distribution
G.I. Windows, Inc.
The GI Windows Titanium Grasper is a surgical laparoscopic grasper with a non-ferrous distal actuator that is intended to be used with GIW’s Self-Forming Magnet (SFM) technology. The grasper’s form factor, handle, length, and actuation will be nearly identical to commercially available laparoscopic graspers that we used every day in the operating room. The primary differentiator of this product will be the titanium distal actuator, which due to its non-ferrous make up, will not create (or minimally create) a magnetic attraction force to the SFM implants while in use in surgery.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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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62468 | Surgical soft-tissue manipulation forceps, scissors-like, reusable |
A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code
[?]Product Code | Product Code Name |
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GEN | Forceps, General & Plastic Surgery |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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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
58a90732-10d2-496b-91ca-8c2234f25bb6
August 15, 2024
1
August 07, 2024
August 15, 2024
1
August 07, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined