DEVICE: MICASEPT ATRAUMATIC TISSUE GRASPER (B09920919060050)

Device Identifier (DI) Information

MICASEPT ATRAUMATIC TISSUE GRASPER
20919-06-005
In Commercial Distribution

SONTEC INSTRUMENTS, INC.
B09920919060050
HIBCC
September 24, 2018
1
040729840 *Terms of Use
MICASEPT ATRAUMA TISSUE GRASPING FORCEPS FOLDING RATCHET DOWN OPENING CURVED DOWN
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Rigid endoscopic grasping forceps, reusable A rigid hand-held, manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with grasping tongs or claws which are operated by scissors-like ring handles at the proximal end of the instrument; it is not an electrosurgical instrument. It is typically made of high-grade stainless steel and is introduced into the body through the working channel of the endoscope to grasp internal structures for observation, excision, and/or biopsy procedures. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
GCJ Laparoscope, General & Plastic Surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K002877 000
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Sterilization

No
Yes
Sterilization Method [?]
Dry Heat Sterilization
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
Length: 300 Millimeter
Device Size Text, specify: 4.5mm Diameter
Device Size Text, specify: 30° Jaw
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Device Record Status

afb1cc73-8438-42e1-9e52-bd10d24b62bc
August 27, 2018
5
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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

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

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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
No
No
No CLOSE

Customer Contact

[?]
8008217496
INFO@SONTECINSTRUMENTS.COM
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