DEVICE: Rumex (00840159908495)
Device Identifier (DI) Information
Rumex
12-RTUB-1
In Commercial Distribution
12-RTUB-1
RUMEX INTERNATIONAL CORP.
12-RTUB-1
In Commercial Distribution
12-RTUB-1
RUMEX INTERNATIONAL CORP.
Reusable Tubing System For The Infusion Of Silicone Oil, Caprolon Adapter Adjustable To Loltech® Pentasys; Optikon® Antares; Alcon® STTO; Storz® Premiere; DORC® Harmony Budget™
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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17003 | Lacrimal tube |
An implantable short tube intended to provide a bypass route for tear drainage from the corner of the eye into the nasal cavity, or a paranasal sinus, as treatment for pathologies of the tear drainage system in association with functional or obstructive epiphora; it may also be intended to facilitate saline solution irrigation to a paranasal sinus (e.g., ethmoid sinus) to manage chronic rhinosinusitis. Also referred to as a lacrimal stent (e.g., Lester Jones type), it is implanted after surgery to dilate or maintain a surgically-created passage [e.g., dacryocystostomy/dacryocystorhinostomy (DCR)], and is made of glass or synthetic polymer materials (e.g., silicone).
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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GAZ | Tubing, Noninvasive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
No
Yes
CLOSE
Yes
Sterilization Method [?] |
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Dry Heat Sterilization |
Ethylene Oxide |
Moist Heat or Steam Sterilization |
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
6e90c626-3964-428c-a14c-62fcda106ee4
June 19, 2020
1
June 11, 2020
June 19, 2020
1
June 11, 2020
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined