Home GUDID 00811714036588 Thunderbolt
Primary DI 00811714036588
Brand Thunderbolt
Company RESPONSIVE ORTHOPEDICS LLC
Model 285970
Catalog number 285970
Device description Thunderbolt Tensioner Middle
Published 2025-05-14
Public version status Update
Distribution status Not 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 LXH Orthopedic Manual Surgical Instrument
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LXH Orthopedic Manual Surgical Instrument Orthopedic 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00811714036588 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 00811714036588 00811714036588 811714036588 0811714036588
GMDN Terms# Term, Definition table Term Definition Suture/ligature tightener, reusable A hand-held manual surgical instrument intended for the in situ tightening of a suture/ligature loop or a suture between a set of suture anchors (not included) during open and/or minimally-invasive surgery (e.g., vascular or gastrointestinal surgery). The suture is intended to be loaded into the device, which typically includes a sliding mechanism or a rigid tube with an internal wire loop for controlled manual tightening; some types may include a non-penetrating fastening device to secure suture ends. This is a reusable device.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 002745858 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true 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 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 00840606186414 ALIF SPINAL ELEMENTS, INC. LXH 2026-08-26