FDA.reportPublic FDA data

CONMED

Primary DI
20845854012793
Brand
CONMED
Company
Conmed Corporation
Model
EL9101
Catalog number
EL9101
Device description
OVAL BUR, EXTENDED LENGTH, (19 CM), 4.0 MM
Published
2021-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854012793PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084585401279320845854012793

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.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10845854061718LASEADAPTLA3010EY10LA3010EY102020-06-01
20653405014147CONMED7-809-47-809-42016-09-24
20653405014154CONMED7-809-57-809-52016-09-24
20653405014178CONMED7-809-77-809-72016-09-24
20845854081584VIROSAFEVSOH002VSOH0022020-06-27
30653405061582DetachaTip3-10093-10092016-09-24
30653405061766DetachaTipIII3-43183-43182016-09-24
20845854649975ParadigmPRBSPRBS2022-02-08
20845854649982ParadigmPRBHPRBH2022-02-08
20845854655501Argo KnotlessKBC475-KITKBC475-KIT2026-09-25
20845854655518Argo KnotlessK475-KITK475-KIT2026-09-25
30845854655478ConMed AirsealSHELF-ICARTSHELF-ICART2026-09-18
20845854082482ParadigmPEZS01APEZS01A2020-11-16
20845854015466SEQUENTMR007CMR007C2015-10-24
20845854036584SEQUENTMR004CMR004C2015-10-24
10653405044703CORE DYNAMICSCD1406CD14062026-03-23
10653405045083CORE DYNAMICSCD1608FHCD1608FH2026-03-24
20653405990908GENESYS™ CrossFT™CFBC-4502RCFBC-4502R2026-07-31
20653405990915GENESYS™ CrossFT™CFBC-4503RCFBC-4503R2026-07-31
20653405990922GENESYS™ CrossFT™CFBC-5502RCFBC-5502R2026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000108G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000109G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
E226000106AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-27
E226000104AL1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
E226000104G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-24
10845854012581VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854012598VORTEX, STERLINGConmed CorporationGFF2023-01-19
10845854017791STERLINGConmed CorporationGFF2023-01-19
10845854029626STERLINGConmed CorporationGFF2023-01-19
10845854029671LIGHTNING, STERLINGConmed CorporationGFF2023-01-19
10845854040621ULTRATIGERConmed CorporationGFF2023-01-19
10080196377299MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10080196385577MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10884389198537MedlineMEDLINE INDUSTRIES, INC.GFF2022-05-12
10653160274797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160276982CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160281672CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160282402CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01
10653160290797CenturionCENTURION MEDICAL PRODUCTS CORPORATIONGFF2022-01-01