Home GUDID 03613720173526 PASS LP
Primary DI 03613720173526
Brand PASS LP
Company MEDICREA INTERNATIONAL
Model B02126007S
Device description ROD Ø 6mm x 70mm
Published 2015-10-16
Public version status Update
Distribution status Not 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 NKB Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03613720173526 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03613720173526 03613720173526 3613720173526
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, sterile An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.
Regulatory Flags# DUNS number 383228632 Device count 1 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 07290115935578 PER Trial 60 PREMIA SPINE LTD NKB 2026-07-22 07290115935691 PER Trial 50 PREMIA SPINE LTD NKB 2026-07-22 00840466901035 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901479 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901486 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901493 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901509 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901516 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901523 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901530 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901547 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901554 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901561 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901578 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901585 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901592 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21 00840466901608 Primus SPINAL ELEMENTS, INC. NKB 2026-07-21