DEVICE: StripRight (B145113900)
Device Identifier (DI) Information
StripRight
11390
In Commercial Distribution
OPTICAL INTEGRITY INC
11390
In Commercial Distribution
OPTICAL INTEGRITY INC
1000 µm StripRight Fiber Strip and Scribe Tool
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
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? |
---|---|---|---|---|
48018 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HRT | STRIPPER, SURGICAL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 10 and 37 Degrees Celsius |
Special Storage Condition, Specify: store at room temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
d5436f8d-3e79-458a-941b-66548e883da0
March 29, 2018
2
November 03, 2016
March 29, 2018
2
November 03, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
B145114921 | 5 | B145113900 | In Commercial Distribution | box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(850)233-5512
customercare@opticalintegrity.com
customercare@opticalintegrity.com