FDA.reportPublic FDA data

Renú Gel

Primary DI
00856509002935
Brand
Renú Gel
Company
CYTOPHIL, INC.
Model
08-015-00-V04
Catalog number
08-015-00-V04
Device description
Renú Gel Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent.
Published
2019-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MIXSystem, Vocal Cord Medialization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIXSystem, Vocal Cord MedializationEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856509002935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856509002935008565090029358565090029350856509002935

GMDN Terms#

Term, Definition table
TermDefinition
Injectable vocal cord medialization implant, syntheticAn implantable synthetic material [e.g., calcium hydroxyapatite, polytetrafluoroethylene (PTFE) -- commonly known as Teflon] designed as a space-occupying bulking agent to treat patients with unilateral vocal cord paralysis to improve voice quality. The device is typically available in a sterile syringe with needle, and is injected into the paralyzed vocal cord tissue, filling it and shifting it midline (vocal cord medialization). The properties of the device may facilitate ingrowth of the surrounding tissue over time. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
024222105
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852108006510Regento Regenerative Scaffold02-100-03-VTX202937-10 2019-10-30
00852108006251Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-01-MIL04-030-01-MIL2019-10-30
00852108006329Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-01-PIB04-030-01-PIB2019-10-30
00852108006312Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-PIB04-010-01-PIB2019-10-30
00852108006305Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-005-01-PIB04-005-01-PIB2019-10-30
00852108006404Callisto Granules Beta-TCP Synthetic Bone Graft02-050-03-VEXVX-233052019-10-30
00856509002584Trab-X SB Synthetic Bone Matrix02-050-02-VTX102937-05 2019-10-30
00852108006367Callisto Granules Beta-TCP Synthetic Bone Graft02-050-02-VEXVX-120052019-10-30
00852108006381Callisto Granules Beta-TCP Synthetic Bone Graft02-200-02-VEXVX-12020 2019-10-30
00852108006411Callisto Granules Beta-TCP Synthetic Bone Graft02-100-03-VEXVX-233102019-10-30
00856509002621Trab-X SB Synthetic Bone Matrix02-050-03-VTX202937-052019-10-30
00856509002638Trab-X SB Synthetic Bone Matrix02-100-03-VTX202937-102019-10-30
00856509002690RegenOsteo Orthopedic Beta-TCP02-050-02-RGO02-050-02-RGO2019-10-30
00856509002706RegenOsteo Orthopedic Beta-TCP02-100-02-RGO02-100-02-RGO2019-10-30
00856509002942Zavation ZV Graft Beta-TCP Synthetic Bone Graft02-030-02-ZVG02-030-02-ZVG2019-10-30
00856509002959Zavation ZV Graft Beta-TCP Synthetic Bone Graft02-030-03-ZVG02-030-03-ZVG2019-10-30
00852108006244Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-MIL04-010-01-MIL2019-10-30
00852108006275Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-02-MIL04-010-02-MIL2019-10-30
00852108006282Implant Logistics Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-02-MIL04-030-02-MIL2019-10-30
00852108006138Implant Logistics Synthetic Biphasic Dental Bone Graft Granules03-005-02-MIL03-005-02-MIL2019-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810235030846Prolaryn Gel MERZ NORTH AMERICA, INC.MIX2026-02-24
14063107101752Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107101769Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
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14063107101783Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
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14063107101806Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
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14063107102636Montgomery® Thyroplasty Measuring KitBoston Medical Products, Inc.MIX2022-08-31
34063107101756Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
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34063107101862Montgomery® Thyroplasty ImplantBoston Medical Products, Inc.MIX2022-08-31
14063107102483Montgomery® Thyroplasty Instrument SetBoston Medical Products, Inc.MIX2022-08-31
14063107102490Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31
14063107102506Montgomery® Thyroplasty InstrumentBoston Medical Products, Inc.MIX2022-08-31