FDA.reportPublic FDA data

Renú Transoral Needle

Primary DI
00856509002669
Brand
Renú Transoral Needle
Company
CYTOPHIL, INC.
Model
12-000-00-ND1
Catalog number
12-000-00-ND1
Device description
Renú Transoral Needle is a manual surgical instrument intended to deliver injectable soft tissue filling devices to the vocal folds for vocal fold medialization and/or treatment of vocal fold insufficiency that may be improved by injection of a soft tissue bulking agent. The needle is a single use device and is provided sterile and ready to use.
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
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856509002669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856509002669008565090026698565090026690856509002669

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose endoscopic needle, single-useA flexible, sterile, sharp bevel-edged, hollow tubular device intended to be manually-operated through a compatible endoscope to perform various needle functions (e.g., injection, aspiration, irrigation, puncture) during endoscopy. It is designed with appropriate shape, materials, gauge, and other characteristics (e.g., high-contrast tips) to function through the working channel of an endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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00852108006299Bio | TCP Beta-Tricalcium Phosphate Porous Granulate04-010-01-BSBBTCP2512019-10-30
00852108006305Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-005-01-PIB04-005-01-PIB2019-10-30
00852108006312Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-010-01-PIB04-010-01-PIB2019-10-30
00852108006329Bank-It Synthetic Beta-Tricalcium Phosphate Dental Bone Graft Granules04-030-01-PIB04-030-01-PIB2019-10-30

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