FDA.report

Double lateral support

Primary DI
04046768028661
Brand
Double lateral support
Company
MAQUET GmbH
Model
100217A0
Published
2022-09-22
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
false

Related Records

Product Codes

CodeName
BWNTABLE AND ATTACHMENTS, OPERATING-ROOM

Product Code Classifications

CodeDeviceSpecialtyClass
BWNTable And Attachments, Operating-RoomGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04046768028661PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04046768028661040467680286614046768028661

GMDN Terms

TermDefinition
Operating table torso positionerA preformed device (e.g., cushion, foam pad, lateral post, bolster, wedge, multi-jointed metal structure) designed to be attached to an operating table for stabilizing a patient's body trunk (e.g., shoulders, chest, pelvis, hips) to adequately position, support, and reduce pressure on the bony prominences of the body part during intraoperative procedures (e.g., orthopaedic surgery). It is typically used when the patient is in the prone, lateral, or Trendelenburg position; it may be adhesive or components for attachment to the operating table (e.g., adaptors, straps) may be included with the device. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
315435859
Device count
1
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
true
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

Primary DIBrandModelCatalogPublished
04046768146600Traction Adapter100372AC2025-11-30
04046768151468Connection Bracket100405A02025-11-30
04046768151475Connection Bracket100405F02025-11-30
04046768151567Traction bar with ball for 1160 and 7700100740B02025-11-30
04046768151574Traction bar for 1160 and 7700100741B02025-11-30
04046768112704Disposable cover100729A02025-06-17
04046768146037Carbon Fiber Table Top116016A02025-01-27
04046768146044Carbon Fiber Table Top116016A12025-01-27
04046768146051Carbon Fiber Table Top116016A22025-01-27
04046768146853Joystick116094A02025-01-27
04046768001954Femur counter traction post table top100485B02022-12-08
04046768148321Retrofit kit head fixation I116036A02024-11-21
04046768148338Extension plate116033DC2024-11-21
04046768148345Extension plate116033BC2024-11-21
04046768148352Extension plate116033GC2024-11-21
04046768150973Extension plate116033FC2024-11-21
04046768151208Retrofit kit head fixation II116036B02024-11-21
04046768145993Universal Remote Control100925B02024-09-18
04046768148475Table width extension, long100175F02024-06-03
04046768148499Bariatric OR Table Set100174F02024-06-03

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