DEVICE: Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX (03701354402201)
Device Identifier (DI) Information
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX
PW C-G-D 90
In Commercial Distribution
PLASMABIOTICS
PW C-G-D 90
In Commercial Distribution
PLASMABIOTICS
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series
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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61446 | Cochlear electrode array introducer, reusable |
A non-sterile, hand-held manual surgical instrument designed to aid insertion of an electrode array into the cochlea during implantation of a cochlear implant. It is typically a thin probe with a clawed distal end mounted on a handle and is made of high-grade stainless steel. 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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LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
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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Storage Environment Temperature: between 15 and 40 Degrees Celsius |
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between .9 and 1.1 Inches of Mercury |
Clinically Relevant Size
[?]Size Type Text |
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Length: 34 Centimeter |
Width: 23 Centimeter |
Height: 3 Centimeter |
Device Record Status
e2204b22-06ef-4b15-9a1e-79816357e158
May 21, 2021
1
May 13, 2021
May 21, 2021
1
May 13, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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