FDA.reportPublic FDA data

Rumex

Primary DI
00840159908495
Brand
Rumex
Company
RUMEX INTERNATIONAL CORP.
Model
12-RTUB-1
Catalog number
12-RTUB-1
Device description
Reusable Tubing System For The Infusion Of Silicone Oil, Caprolon Adapter Adjustable To Loltech® Pentasys; Optikon® Antares; Alcon® STTO; Storz® Premiere; DORC® Harmony Budget™
Published
2020-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GAZTubing, Noninvasive

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAZTubing, NoninvasiveGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840159908495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840159908495008401599084958401599084950840159908495

GMDN Terms#

Term, Definition table
TermDefinition
Lacrimal tubeAn 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).

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

Regulatory Flags#

DUNS number
041546137
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840159900345Rumex18-30418-3042020-06-09
00840159900406Rumex18-30518-3052020-06-09
00840159900802Rumex18-30318-3032020-06-09
00840159903384Rumex18-30118-3012020-06-09
00840159903391Rumex18-301-118-301-12020-06-09
00840159903407Rumex18-30218-3022020-06-09
00840159903414Rumex18-30718-3072020-06-09
00840159903421Rumex18-30818-3082020-06-09
00840159903438Rumex18-31818-3182020-06-09
00840159905609Rumex18-30018-3002020-06-09
00840159907900Rumex18-300-118-300-12020-06-09
00840159907917Rumex18-303-118-303-12020-06-09
00840159907924Rumex18-305-118-305-12020-06-09
00840159907931Rumex18-31018-3102020-06-09
00840159907948Rumex18-31118-3112020-06-09
00840159907955Rumex18-31218-3122020-06-09
00840159907962Rumex18-31318-3132020-06-09
00840159907979Rumex18-31418-3142020-06-09
00840159902189Rumex9-011S9-011S2020-06-04
00840159902196Rumex9-012S9-012S2020-06-04

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Primary DI, Brand, Company table
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10840113242754BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-18
10840113242778BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-18
00840113242764BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-04
00840113242771BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-04
00840113242818BovieASPEN SURGICAL PRODUCTS, INC.GAZ2026-09-04
00810194403514AiraAIRA, LLCGAZ2026-08-26
00840329834494BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GAZ2026-07-30
00840329836856BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.GAZ2026-07-30
10080196992805MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-22
10080196144310MEDLINEMEDLINE INDUSTRIES, INC.GAZ2026-06-08
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10885380072352CARDINAL HEALTHCardinal Health 200, LLCGAZ2026-02-13
10080196035106MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
10080196035120MEDLINEMEDLINE INDUSTRIES, INC.GAZ2025-04-25
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10192253042917ArgyleCardinal Health 200, LLCGAZ2025-02-27
10192253043051ArgyleCardinal Health 200, LLCGAZ2025-02-27
08809083944803EvaQMax LaparoBIOPROTECH INC.GAZ2024-08-28
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