FDA.report

Spine Instruments

Primary DI
08033860020057
Brand
Spine Instruments
Company
BIOPSYBELL SRL
Model
03.52.10.0469
Device description
K-Wire Ø1.5x600mm - Sharp NiTi - Marking- STERILE
Published
2020-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GDFGuide, Needle, Surgical
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GDFGuide, Needle, SurgicalGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033860020057PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033860020057080338600200578033860020057

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Device Sizes

TypeValueUnit
Length600Millimeter
Outer Diameter1.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+39053527850support@biopsybell.it

Regulatory Flags

DUNS number
438746708
Device count
1
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
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 DIBrandModelCatalogPublished
08033860021603SOMATEXSOMACORE VERIFY900380-US2016-08-01
08033860021627SOMATEXSOMACORE VERIFY900382-US2016-08-01
08033860021641SOMATEXSOMACORE VERIFY900390-US2016-08-01
08033860021665SOMATEXSOMACORE VERIFY900392-US2016-08-01
08033860021689SOMATEXSOMACORE VERIFY900400-US2016-08-01
08033860021702SOMATEXSOMACORE VERIFY900402-US2016-08-01
08033860021726SOMATEXSOMACORE VERIFY900404-US2016-08-01
08033860021740SOMATEXSOMACORE VERIFY900410-US2016-08-01
08033860021764SOMATEXSOMACORE VERIFY900412-US2016-08-01
08033860021788SOMATEXSOMACORE VERIFY S900480-US2016-08-01
08033860021801SOMATEXSOMACORE VERIFY S900490-US2016-08-01
08033860021825SOMATEXSOMACORE VERIFY S900492-US2016-08-01
08033860021849SOMATEXSOMACORE VERIFY S900500-US2016-08-01
08033860021863SOMATEXSOMACORE VERIFY S900502-US2016-08-01
08033860034757BIOPSYBELLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVELRESWB1112C-US2020-06-12
08033860034764BIOPSYBELLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCARESWTR1112C-US2020-06-12
08033860034771BIOPSYBELLRENOVA SPINE KYPHOPLASTY DRILLRESDRI1112C-US2020-06-12
08033860034818BIOPSYBELLRENOVA SPINE BONE FILLERRESFIL1112C1-US2020-06-12
08033860037314BIOPSYBELL SRLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVELRESWBTR1112C-US2022-09-28
08033860043643BIOPSYBELLRENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVELRESWB0812C-US2024-02-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04048844738150implaFit®implantcast GmbHLXH2026-03-24
07630542779244Surgical Manual InstrumentMedacta International SALXH2026-03-24
08053782783656BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783663BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783670BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783687BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783694BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783700BRM INSTRUMENTBRM EXTREMITIES SRLLXH2026-03-24
08053782783748TOOL VIP XL Instruments KitBRM EXTREMITIES SRLLXH2026-03-24
10888857596986K2M General InstrumentsK2M, INC.LXH2026-03-24
10888857596993K2M General InstrumentsK2M, INC.LXH2026-03-24
24026704941630PILLINGTELEFLEX INCORPORATEDLXH2026-03-23
00199150044016Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150067343Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043989Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150043996Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00199150044009Medtronic Reusable Instruments and AccessoriesMEDTRONIC SOFAMOR DANEK, INC.LXH2026-03-22
00198506089718ELMED INCORPORATEDELMED INCORPORATEDLXH2026-03-20
00810166520003X-PACEXPANDING INNOVATIONS, INC.LXH2026-03-20
00840314270221gSourceGSOURCE LLCLXH2026-03-20
00840314270238gSourceGSOURCE LLCLXH2026-03-20
10705034577678N/AMedos International SàrlLXH2026-03-20
00190446898801Arsenal FootTrilliant Surgical, LLCLXH2026-03-19
008890247065832 Piece Modular Shell Adapter BoltZimmer, Inc.LXH2026-03-19
008890247065902 Piece Modular Shell AdapterZimmer, Inc.LXH2026-03-19
03700879518589PECAPLASTY®NOVASTEPLXH2026-03-19
03700879518596PECAPLASTY®NOVASTEPLXH2026-03-19
07630542789984Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542789991Surgical Manual InstrumentMedacta International SALXH2026-03-19
07630542797576Surgical Manual InstrumentMedacta International SALXH2026-03-19