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
03701354402201
GS1

1
262972663 *Terms of Use
Silicone connection set for colonoscopes, gastroscopes and duodenoscopes PENTAX 90 and i10 series
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Device Characteristics

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

GMDN

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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?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

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

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
Length: 34 Centimeter
Width: 23 Centimeter
Height: 3 Centimeter
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Device Record Status

e2204b22-06ef-4b15-9a1e-79816357e158
May 21, 2021
1
May 13, 2021
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
Yes CLOSE

Customer Contact

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No Customer Contact currently defined
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