Home GUDID 00845694026727 OsteoMed
Primary DI 00845694026727
Brand OsteoMed
Company OSTEOMED LLC
Model 800-0115
Catalog number 800-0115
Device description PrimaLOK SP 15mm Implant Assembly
Published 2015-05-22
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 KWP APPLIANCE, FIXATION, SPINAL INTERLAMINAL
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00845694026727 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00845694026727 00845694026727 845694026727 0845694026727
GMDN Terms# Term, Definition table Term Definition Orthopaedic fixation plate kit, non-bioabsorbable, non-sterile A non-sterile collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the component material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.
Device Sizes# Type, Value, Unit table Type Value Unit Height 15 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 606417780 Device count 1 DM exempt true Lot or batch true Manufacturing 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 00840466901035 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901042 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901059 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901066 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901073 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901080 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901097 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901103 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901110 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901127 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901141 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901158 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901165 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901172 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901479 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901486 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901493 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901509 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901516 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901523 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901530 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901547 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901554 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901561 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901578 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901585 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901592 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901608 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901615 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21 00840466901622 Primus SPINAL ELEMENTS, INC. KWP 2026-07-21
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