FDA.reportPublic FDA data

HALL OSTEON

Primary DI
20845854023218
Brand
HALL OSTEON
Company
Conmed Corporation
Model
5038-002
Catalog number
00503800200
Device description
HALL OSTEON ANGLED HANDPIECE
Published
2020-09-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GETMOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GETMotor, Surgical Instrument, Pneumatic PoweredGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K833187000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K833187000HALL OSTEONAmsco Co.1983-10-31GET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20845854023218Direct MarkingGS10
20845854044923PrimaryGS10
30845854023215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084585402321820845854023218
2084585404492320845854044923
3084585402321530845854023215

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system handpiece, sawing, pneumaticA pneumatically-powered, hand-held device that consists of a motorized handpiece that provides sagittal, oscillating, or reciprocating movement for attachable serrated blades to cut through hard/tough tissue during surgery. The device may be of the micro or macro design and is typically powered by a compressed gas [e.g., surgical-grade air or nitrogen (N2)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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
08809317170671LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170701LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170817LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317171012LEOPARDIMEDICOM CO., LTD.GET2023-07-10
08809317170657LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170664LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170695LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08809317170824LEOPARDIMEDICOM CO., LTD.GET2023-07-05
08800038048270LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048287LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048294LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048300LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038053151LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038055421LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055438LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055445LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-21
08800038055469LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08809317170800LEOPARDIMEDICOM CO., LTD.GET2023-06-21
08800038048645LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
08800038048652LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
08800038055452LEOPARD MicroIMEDICOM CO., LTD.GET2023-06-20
06946998817265BojinShanghai Bojin Electric Instrument & Device Co., Ltd.GET2022-12-29
05051471038820De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471047631De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471085596De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471098152De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471105577De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471107397De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471107410De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28
05051471109773De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGET2022-11-28