Home GUDID 00811836030105 TrenGuard™
Primary DI 00811836030105
Brand TrenGuard™
Company D. A. Surgical
Model 55201
Device description TrenGuard 450 HYBRID Packs - Each 2-piece Pack contains: "Speed Bump" Bolster and Head Stabilizing Pillow. For use with Reusable Lateral Stabilizing Pillows as part of HYBRID system. Weight limit up to 204 kg. Case of 12 ea. 00811836030105 (model #55104)
Published 2021-05-17
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name BWN Table And Attachments, Operating-Room CCX Support, Patient Position
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class BWN Table And Attachments, Operating-Room General, Plastic Surgery 1 CCX Support, Patient Position Anesthesiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10811836030102 Primary GS1 0 00811836030105 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10811836030102 10811836030102 00811836030105 00811836030105 811836030105 0811836030105
GMDN Terms# Term, Definition table Term Definition Operating table patient positioning set, single-use A collection of devices intended to support and stabilize in a desired position a patient, or their body parts, on an operating table during a medical procedure (e.g., bariatric surgery, orthopaedic surgery, endotracheal tube intubation); some types may be intended to prevent patient sliding while in the Trendelenburg position or when applying traction. The set consists of multiple items which include two or more of the following: padded positioners dedicated to a body part such as arm, leg, shoulder, neck, or feet positioner, a headrest, a non-slip pad/bolster placed underneath the patient (e.g., cervical notch), and securing devices (e.g., straps). This is a single-use device.
Regulatory Flags# DUNS number 040876183 Device count 12 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true 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 false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00787551041668 LPK10037 Lateral Positioning Kit XODUS MEDICAL, INC. CCX 2026-10-19 00787551041675 LPK10036 Lateral Positioning Kit XODUS MEDICAL, INC. CCX 2026-10-19 00787551041682 SPK10756 Surgical BackPack Kit XODUS MEDICAL, INC. CCX 2026-10-19 00860003986844 GENESIS BI-WING XL GEN 3.0 Infinitus Medical Technologies LLC CCX 2026-10-15 00860014205507 PNEUMA GENESIS BI-WIUNG POSITIONING SYSTEM Infinitus Medical Technologies LLC CCX 2026-10-15 00724995363321 NA STERIS CORPORATION BWN 2026-10-08 00724995363338 NA STERIS CORPORATION BWN 2026-10-08 00724995363345 NA STERIS CORPORATION BWN 2026-10-08 00724995363352 NA STERIS CORPORATION BWN 2026-10-08 00724995363888 NA STERIS CORPORATION BWN 2026-10-08 00724995363895 NA STERIS CORPORATION BWN 2026-10-08 00842102116506 StrongArm Surgical Holders and Positioners FLEXBAR MACHINE CORPORATION BWN 2026-10-07 00815849025615 Custom Medical Specialties, Inc. CUSTOM ASSEMBLIES, INC. BWN 2026-10-06 09421905187794 Adept Medical Lateral Support Single ADEPT MEDICAL LIMITED CCX 2026-10-05 09421905187800 Adept Medical Lateral Support Pair ADEPT MEDICAL LIMITED CCX 2026-10-05 09421905187817 Adept Medical Lateral Vacuum Brace ADEPT MEDICAL LIMITED CCX 2026-10-05 00851674008683 SmartSurface Riser - Stryker D860 Elucent Medical, Inc. BWN 2026-09-28 15060797554775 NA David Scott Company CCX 2026-09-25 00850047863799 SurgiLock Medicalock Corporation CCX 2026-09-24 00850047863829 SurgiLock Medicalock Corporation CCX 2026-09-24 00850047863836 CerviLock Medicalock Corporation CCX 2026-09-24 00749756401739 DeRoyal DEROYAL INDUSTRIES, INC. CCX 2026-09-18 00848530109783 Oxygen Accessory Sunset Healthcare Solutions, Inc. CCX 2026-09-09 00842102116469 Flexarm Surgical Holders and Positioners FLEXBAR MACHINE CORPORATION BWN 2026-08-03 00787551041637 SPK11761 Jackson Table Kit XODUS MEDICAL, INC. CCX 2026-07-27 00787551041644 SPK11773 Surgical BackPack Kit XODUS MEDICAL, INC. CCX 2026-07-27 00787551041651 SPK11774 Surgical BackPack Kit XODUS MEDICAL, INC. CCX 2026-07-27 00851440007902 Responsive Respiratory, Inc. RESPONSIVE RESPIRATORY, INC. CCX 2026-07-22 00811836030907 TrenGuard™ Dan Allen Surgical LLC CCX 2026-06-26 00811836030921 TrenGuard™ Dan Allen Surgical LLC CCX 2026-06-26