DEVICE: Toothed Grasper, Magnetic Surgical System (00852342007007)

Device Identifier (DI) Information

Toothed Grasper, Magnetic Surgical System
TGR001
In Commercial Distribution

LEVITA MAGNETICS INTERNATIONAL CORPORATION
00852342007007
GS1

1
066172261 *Terms of Use
Magnetic Surgical System Toothed Grasper,
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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?
62415 Magnetic surgical manipulation system instrument, internal
A sterile, invasive, magnetic device intended to be percutaneously inserted into the body to be used as a manoeuvrable object to permit transcutaneous grasping/manipulation/retraction of soft tissues/organs (e.g., gallbladder) during endoscopic/laparoscopic procedures, via magnetic coupling with an external magnetic device moved across the patient’s body surface by the operator. It is made of plastic and metal materials and may be in the form of a grasper, bent rod, or other shape designed to contact the target tissue/organ; dedicated tools to assist its insertion/retrieval are typically included. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
PNL Magnetic Surgical System
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
DEN150007 000
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

c60657f5-29b6-48e3-a27d-b8aef40f58f8
July 06, 2018
3
October 18, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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