Home GUDID 08033860029166 BIOPSYBELL
Primary DI 08033860029166
Brand BIOPSYBELL
Company BIOPSYBELL SRL
Model BONE ACCESS NEEDLE
Catalog number BAN1312CDT
Device description BONE ACCESS NEEDLE
Published 2023-06-26
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 Product Codes# Code, Name table Code Name LXH Orthopedic Manual Surgical Instrument OCJ Spinal Channeling Instrument, Vertebroplasty
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1 OCJ Spinal Channeling Instrument, Vertebroplasty Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 08033860029166 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 08033860029166 08033860029166 8033860029166
GMDN Terms# Term, Definition table Term Definition Bone access channel kit A collection of sterile manual devices intended to create a percutaneous access channel within a vertebral body or other bones (e.g., hand, radius, tibia, calcaneus) prior to the use of an inflatable balloon (e.g., a balloon catheter or balloon tamp) to create a bone space during kyphoplasty/osteoplasty. It typically consists of bone access needles/cannulae, orthopaedic bone wires (Kirschner wires), a drill, and a curette. It is used in orthopaedic surgery, typically under fluoroscopic guidance, to treat a patient diagnosed with compression fractures. This is a single-use device.
Device Sizes# Type, Value, Unit table Type Value Unit Length 120 Millimeter Needle Gauge 13 Gauge
Regulatory Flags# DUNS number 438746708 Device count 1 Premarket exempt true Lot or batch true Expiration date on label true No natural rubber latex true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M9432002220000 Minuteman Spinal Simplicity, LLC LXH 2026-09-04 07613327697209 PANGEA Stryker GmbH LXH 2026-08-27 00840606185950 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185967 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185974 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185981 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606185998 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186001 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186018 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186025 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186032 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186049 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186056 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186063 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186070 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186087 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186094 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186100 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186117 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186124 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186131 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186148 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186155 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186162 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186179 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186186 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186193 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186209 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186247 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26 00840606186254 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26
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