FDA.report

RAPHAEL

Primary DI
00841732128583
Brand
RAPHAEL
Company
CTL MEDICAL CORPORATION
Model
115.7078
Published
2019-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841732128583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841732128583008417321285838417321285830841732128583

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(214)545-5820complaints@ctlmed.com

Regulatory Flags

DUNS number
080138504
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
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

Primary DIBrandModelCatalogPublished
00841732168664MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17112026-01-08
00841732168671MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17132026-01-08
00841732168688MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17152026-01-08
00841732168695MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17172026-01-08
00841732168701MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17192026-01-08
00841732168718MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17512026-01-08
00841732168725MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17532026-01-08
00841732168732MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17552026-01-08
00841732168749MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17572026-01-08
00841732168756MONDRIAN ALIF Cage with Supplementary Fixation Plate120.17592026-01-08
00841732168763MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19132026-01-08
00841732168770MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19152026-01-08
00841732168787MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19172026-01-08
00841732168794MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19192026-01-08
00841732168800MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19532026-01-08
00841732168817MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19552026-01-08
00841732168824MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19572026-01-08
00841732168831MONDRIAN ALIF Cage with Supplementary Fixation Plate120.19592026-01-08
00841732167483Generic100.77552024-12-10
00841732167490Generic100.77652024-12-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00763000887070CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000887155CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000992033MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-14
00841732108134RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108141RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108158RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108165RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108172RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108189RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108196RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108202RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108219RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108226RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122529RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122536RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732131835RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145085RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145092RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00840996188715THUNDERBOLT Minimally Invasive Pedicle Screw SystemsChoice Spine, LPMNH2023-02-03
088000333584424CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2018-08-17
00841732117822RAPHAELCTL MEDICAL CORPORATIONMNH2017-08-07
00841732117839RAPHAELCTL MEDICAL CORPORATIONMNH2017-08-07
088000333847004CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2016-10-28
088000333847314CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2016-10-28
088000333842054CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2016-10-28
088000333842294CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2016-10-28
088000333842364CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2016-10-28
088000333842434CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2016-10-28
088000333842504CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2016-10-28
088000333842674CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2016-10-28