DEVICE: StripRight (B145113900)

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Device Identifier (DI) Information

StripRight
11390

OPTICAL INTEGRITY INC
B145113900
HIBCC
1
1000 µm StripRight Fiber Strip and Scribe Tool
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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
Laser fibre stripper A non-sterile, hand-held device used by authorized medical personnel to strip the outer protective layer (i.e., casing, jacket or buffer) from the end of a laser fibreoptic device without damaging the fibreoptics so that the bared end can be prepared for the next procedure (e.g, cleaving and repair). It is available in various designs and configurations, e.g., in the form of an electrical cable stripper (a pliers-like device) with two blades that hinge at a proximal end which are clamped over the fibreoptic device to be stripped and a mechanically adjustable depth limiter. It is configured to accept and strip one size or type of fibreoptic.
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FDA Product Code

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Product Code Product Code Name
HRT STRIPPER, SURGICAL
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 10 and 37 Degrees Celsius
Special Storage Condition, Specify: store at room temperature
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 03, 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
B145114921 5 B145113900 In Commercial Distribution box
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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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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+1(850)233-5512
customercare@opticalintegrity.com
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