FDA.reportPublic FDA data

NA

Primary DI
20845854018597
Brand
NA
Company
Conmed Corporation
Model
H9103RH
Catalog number
H9103RH
Device description
5.0MM STERLING OVAL BUR, 6 EA
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
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
20845854018597PackageGS16In Commercial Distribution
10845854018590PrimaryGS10
00845854018593Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585401859720845854018597
1084585401859010845854018590
00845854018593008458540185938458540185930845854018593

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
Outer Diameter5Millimeter

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
20653405037573CONMEDPCD10PCD102016-09-24
10653405063797CONMED75200752002026-03-24
00845854035590CONCEPTESA-5190ESA-51902026-03-24
10845854041116POWERPROPRO2000PRO20002026-03-24
10845854041291CONMEDLS7501LS75012026-03-24
00653405014952POOLE903507090350702026-03-24
20653405017759CONMEDD8324D83242026-03-24
20653405017766CONMEDD8324IID8324II2026-03-24
20653405019777CONMEDDA36-03DA36-032026-03-24
20653405022821CONMEDFSR1303FSR13032026-03-24
20653405022838CONMEDFSR1311FSR13112026-03-24
20653405022951CONMEDFSR1370FSR13702026-03-24
20653405023057CONMEDFSR1534FSR15342026-03-24
20653405023071CONMEDFSR1539FSR15392026-03-24
20653405023163CONMEDFSR1590FSR15902026-03-24
20653405023170CONMEDFSR1590-20FSR1590-202026-03-24
20653405023385CONMEDFSR380FSR3802026-03-24
20653405023545CONMEDFSR565FSR5652026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24053613296209Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-20
07613327687637N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687644N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687651N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687668N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687675N/ASTRYKER CORPORATIONGFF2026-03-19
24053613295929Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613295936Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296131Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296193Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296803Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297121Bur, cylindrical, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297190Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297206Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297220Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
10888867516950Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517926Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517933Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517940Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517957Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517964Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544052Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544069Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544076Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544083Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544090Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544106Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544120Arthrex®ARTHREX, INC.GFF2026-03-03
04027497285884GT PODO 0.276 in (7 mm) round Shank 3/32"LUKAS-ERZETT GmbH & Co. KGGFF2026-02-11
04027497285822GT PODO 0.394 in (10 mm) round Shank 3/32"LUKAS-ERZETT GmbH & Co. KGGFF2026-02-10