FDA.report

BioScrew HyperFlex

Primary DI
20845854041724
Brand
BioScrew HyperFlex
Company
Conmed Corporation
Model
C8027D
Catalog number
C8027D
Device description
BioScrew HyperFlex Guidewire, Nitinol, 18.5in, Sterile
Published
2021-10-12
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

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20845854041724PackageGS11In Commercial Distribution
10845854041727PrimaryGS10
00845854041720Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2084585404172420845854041724
1084585404172710845854041727
00845854041720008458540417208458540417200845854041720

GMDN Terms

TermDefinition
Surgical drill guide, single-useA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags

DUNS number
071595540
Device count
5
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 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 DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091001ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091018ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00841523181360Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181681Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181698Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181704Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181711Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181728Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181735Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181742Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181759Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181766Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181773Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181780Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181797Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181803Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181810Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181827Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181834Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181841Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181858Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26
00841523181865Kyocera Medical Technologies, Inc.KYOCERA MEDICAL TECHNOLOGIES, INC.LXH2026-05-26