Home GUDID 00814008025565 Boundary
Primary DI 00814008025565
Brand Boundary
Company NVision Biomedical Technologies, Inc.
Model BUT-1000T-TAP
Device description Instrument, Lumbar Buttress Plate Tap. The Boundary Anterior Lumbar Buttress Plate is intended to stabilize the allograft or autograft at one level (L1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
Published 2018-07-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false
Product Codes# Code, Name table Code Name KWQ Appliance, Fixation, Spinal Intervertebral Body
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00814008025565 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 00814008025565 00814008025565 814008025565 0814008025565
GMDN Terms# Term, Definition table Term Definition Bone tap, reprocessed A sterile, metal, surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end, and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached, whereby it will typically be manually rotated. This is a previously used single-use device that has been processed for an additional single-use patient application.
Storage And Handling# Type, Low, High table Type Low High Condition Special Storage Condition, Specify 0 0 A complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at any time
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 047486041 Device count 1 DM exempt false Premarket exempt false 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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00840493426426 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426433 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426440 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426457 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426464 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426471 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426488 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426495 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426501 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426518 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426525 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426532 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426549 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426556 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426563 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426570 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426587 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426594 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426600 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426617 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426624 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00840493426631 RIVA Pedicle Screw System XENIX MEDICAL LLC KWQ 2026-08-18 00810056995638 corra Carlsmed, Inc. KWQ 2026-08-17 00193982673475 CREO GLOBUS MEDICAL, INC. KWQ 2026-08-14 00193982673499 CREO GLOBUS MEDICAL, INC. KWQ 2026-08-14 00193982673505 CREO GLOBUS MEDICAL, INC. KWQ 2026-08-14 00193982673529 CREO GLOBUS MEDICAL, INC. KWQ 2026-08-14 00193982673536 CREO GLOBUS MEDICAL, INC. KWQ 2026-08-14 00193982673550 CREO GLOBUS MEDICAL, INC. KWQ 2026-08-14 00193982673567 CREO GLOBUS MEDICAL, INC. KWQ 2026-08-14