FDA.reportPublic FDA data

Imperial Relton-Hall Operating Frame c/w Vinyl Pad

Primary DI
07540162041426
Brand
Imperial Relton-Hall Operating Frame c/w Vinyl Pad
Company
Imperial Surgical Ltd
Model
OR-6050
Catalog number
OR-6050
Device description
Relton-Hall Operating Frame c/w Vinyl Pad Supports
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540162041426PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540162041426075401620414267540162041426

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
514-631-7988info@surgme.com

Regulatory Flags#

DUNS number
245253575
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540162042867HugAire 2 Cu.Ft.Single Compartment Warming CabinetOR-9000-FBLK2026-04-24
07540162040351Conductive Seat Cover and PadOR-3629OR-36292023-07-28
07540162040313Imperial Stainless Steel Revolving StoolOR-36200OR-362002021-01-13
07540162040320Imperial Stainless Steel Revolving StoolOR-36210OR-362102021-01-13
07540162040337Imperial Stainless Steel Revolving StoolOR-36220OR-362202021-01-13
07540162040344Imperial Stainless Steel Revolving StoolOR-36230OR-362302021-01-13
07540162042522"Imperial Overall Dimensions: 40""Lx25.5""Wx44.5""H "OR-3692G-CUSTOR-3692G-CUST2024-11-27
07540162040825Imperial Antimicrobial IV Pole with CUVERRO SHIELDOR-36770-R1OR-36770-R12021-01-13
07540162040832Imperial Antimicrobial IV Pole with CUVERRO SHIELDOR-36760-25OR-36760-252021-01-13
07540162040849Imperial Antimicrobial IV Pole with CUVERRO SHIELDOR-36760-253 OR-36760-253 2021-01-13
07540162040856Imperial Antimicrobial IV Pole with CUVERRO SHIELDOR-36771-25OR-36771-252021-01-13
07540162040863Imperial Antimicrobial IV Pole with CUVERRO SHIELDOR-36771-253OR-36771-2532021-01-13
07540162040870Imperial Hooks & Ram HornsOR-36499OR-364992021-01-13
07540162040887Imperial Hooks & Ram HornsOR-36500OR-365002021-01-13
07540162040894Imperial Hooks & Ram HornsOR-36501OR-365012021-01-13
07540162040900Imperial Hooks & Ram HornsOR-36502OR-365022021-01-13
07540162040917Imperial Hooks & Ram HornsOR-36504OR-365042021-01-13
07540162040924Imperial Hooks & Ram HornsV-50002V-500022021-01-13
07540162040931Imperial Hooks & Ram HornsV-40000V-400002021-01-13
07540162040948Imperial Hooks & Ram HornsV-40001V-400012021-01-13

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