FDA.reportPublic FDA data

RHINOTEC

Primary DI
10845854011935
Brand
RHINOTEC
Company
Conmed Corporation
Model
N9375
Catalog number
N9375
Device description
4.5MM RHINOTEC 45 DEGREE VORTEX
Published
2020-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EQJBUR, EAR, NOSE AND THROAT
GFABLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EQJBur, Ear, Nose And ThroatEar, Nose, Throat1
GFABlade, Saw, General & Plastic Surgery, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845854011935PackageGS16In Commercial Distribution
20845854011932PrimaryGS10
00845854011938Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084585401193510845854011935
2084585401193220845854011932
00845854011938008458540119388458540119380845854011938

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, single-useA sterile, powered, rotational, cutting device designed for use in an arthroscopic shaver system handpiece for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is locked into a handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector. The inner and outer tubes are typically made of high-grade stainless steel; the hub and connector may be made of stainless steel or a polymer [e.g., polyphenylsulfone (PPSU)]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle45degree
Outer Diameter4.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)237-0169CUSTOMER_SERVICE@CONMED.COM
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
6
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327576801PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576825PELLOSTRYKER CORPORATIONEQJ2024-11-13
07613327576566PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576672PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576696PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576719PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576733PELLOSTRYKER CORPORATIONGFA2023-09-13
07613327576740PELLOSTRYKER CORPORATIONGFA2023-09-13
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAEQJ2023-02-22
07630055506467Micro Ear Drill, 12kBien-Air Surgery SAEQJ2023-02-22
07630055506542HS Diam. Burr, Ø0.6x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506559HS Diam. Burr, Ø0.8x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506566HS Diam. Burr, Ø1.0x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506573HS Diam. Burr, Ø1.4x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506580HS Diam. Burr, Ø1.8x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506597HS Diam. Burr, Ø2.3x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506603HS Diam. Burr, Ø2.7x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506610HS Diam. Burr, Ø3.1x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055506627HS Diam. Burr, Ø3.5x70, 50kBien-Air Surgery SAEQJ2023-02-22
07630055505507ShBlade Straight Ø3.0 DS RU StBien-Air Surgery SAEQJ2023-02-17
07630055505514ShBlade Straight Ø3.5 DS RU StBien-Air Surgery SAEQJ2023-02-17
07630055505521ShBlade Straight Ø4.0 DS RU StBien-Air Surgery SAEQJ2023-02-17
07630055505842RAPIDO MicromotorBien-Air Surgery SAEQJ2023-02-10
07630055505910PM2-S125Bien-Air Surgery SAEQJ2023-02-10
07630055505927PM2-S150Bien-Air Surgery SAEQJ2023-02-10