DEVICE: TROCAR INTRODUCER FOR LTF 5 MM SCOPE (04953170316159)

Device Identifier (DI) Information

TROCAR INTRODUCER FOR LTF 5 MM SCOPE
MAJ-1379
In Commercial Distribution

OLYMPUS MEDICAL SYSTEMS CORP.
04953170316159
GS1

1
711789789 *Terms of Use
MAJ-1379 TROCAR INTRODUCER FOR LTF 5MM S
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Endoscopic-access dilator, reusable A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. 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
HET LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K955403 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide
High-level Disinfectant
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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
No Device Sizes
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Device Record Status

c714837c-0144-42eb-af10-1e9d6ca01fd6
July 06, 2018
4
September 21, 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
Yes
No CLOSE

Customer Contact

[?]
+1(800)401-1086
xx@xx.xx
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