Home GUDID 03613720234845 PASS LP
Primary DI 03613720234845
Brand PASS LP
Company MEDICREA INTERNATIONAL
Model B99140630
Device description UNI-PLANAR CONNECTOR
Published 2015-10-23
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 03613720234845 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 03613720234845 03613720234845 3613720234845
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile An assembly of non-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. Non-sterile disposable devices associated with implantation may be included.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 383228632 Device count 1 Lot or batch true Expiration date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00763000992026 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. OSH 2026-08-02 00643169465879 MSB CD HORIZON Spinal System MEDTRONIC SOFAMOR DANEK, INC. OSH 2026-06-28 00193982572983 CREO GLOBUS MEDICAL, INC. OSH 2026-06-10 00887517656582 ReLine Nuvasive, Inc. OSH 2026-04-15 00887517656599 ReLine Nuvasive, Inc. OSH 2026-04-15 00887517656605 ReLine Nuvasive, Inc. OSH 2026-04-15 00887517656612 ReLine Nuvasive, Inc. OSH 2026-04-15 00887517656629 ReLine Nuvasive, Inc. OSH 2026-04-15 10888857047716 MESA® Small Stature Spinal System VB Spine LLC OSH 2015-09-24 07613154110025 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110032 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110049 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110056 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110063 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110070 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110087 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110148 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110155 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110216 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154110223 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122332 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122356 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122363 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122370 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122387 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122394 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122400 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122417 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122424 XIA 4 5 Stryker Corporation OSH 2014-12-08 07613154122516 XIA 4 5 Stryker Corporation OSH 2014-12-08