FDA.reportPublic FDA data

FASSIER-DUVAL TELESCOPIC IM SYSTEM

Primary DI
07540194017772
Brand
FASSIER-DUVAL TELESCOPIC IM SYSTEM
Company
Orthopediatrics Canada ULC
Model
FD-PEG-CSIN175
Catalog number
FD-PEG-CSIN175
Device description
FULL PEG INSTRUMENT CASE
Published
2024-09-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041393000FASSIER-DUVAL TELSCOPIC IM SYSTEMPega Medical, Inc.2004-08-17HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540194017772PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194017772075401940177727540194017772

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(450)688-5144egarcia@orthopediatrics.ca

Regulatory Flags#

DUNS number
243298854
Device count
1
Kit
true
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540194018168Dr.Paleys Osteotomy SystemDRPO-706DRPO-7062026-03-11
07540194013163The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPOP-IMP100-CPOP-IMP100-C2021-11-30
07540194008916The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPOP-CAP100POP-CAP1002020-08-12
07540194009067The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPOP-IMP100POP-IMP1002020-08-12
07540194002181GAP ENDO-EXO MEDULLARY SYSTEMGAP-CP015GAP-CP0152016-10-20
07540194002198GAP ENDO-EXO MEDULLARY SYSTEMGAP-CP050GAP-CP0502016-10-20
07540194002204GAP ENDO-EXO MEDULLARY SYSTEMGAP-CP100GAP-CP1002016-10-20
07540194002396FREE GLIDING SCFE SCREW SYSTEMSCF-MC-065SCF-MC-0652016-10-20
07540194002570FREE GLIDING SCFE SCREW SYSTEMSCF-MC-073SCF-MC-0732016-10-20
07540194004215SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-315SLM-CAP-3152016-10-20
07540194004222SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-350SLM-CAP-3502016-10-20
07540194004239SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-415SLM-CAP-4152016-10-20
07540194004246SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEMSLM-CAP-450SLM-CAP-4502016-10-20
07540194009982GAP ENDO-EXO MEDULLARY SYSTEMGAP-KDG360-PKG2GAP-KDG360-PKG22020-08-12
07540194009999GAP ENDO-EXO MEDULLARY SYSTEMGAP-KDG360-PKG6GAP-KDG360-PKG62020-08-12
07540194016737GAP ENDO-EXO MEDULLARY SYSTEMGAP-SDG200GAP-SDG2002024-06-13
07540194009975GAP ENDO-EXO MEDULLARY SYSTEMGAP-KDG360GAP-KDG3602020-08-12
07540194017956GIRO GROWTH MODULATION SYSTEMGRO-CYF250-35GRO-CYF250-352025-03-31
07540194015907HINGE PEDIATRIC PLATING SYSTEMHP-CYF250HP-CYF2502024-09-11
07540194015921GIRO GROWTH MODULATION SYSTEMGRO-CYF150-45GRO-CYF150-452024-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS186950Aligned Medical SolutionsAligned Medical SolutionsOJH2026-08-03
10198956372849CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956423824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956439429CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956483613CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956495333CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956497849CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956500150CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956503106CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956503182CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956506824CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956510333CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956510869CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956512504CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956512566CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956516076CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956518728CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956521230CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956521308CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956523777CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956523838CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956529601CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956532380CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533455CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533462CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956533868CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534216CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534445CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956534995CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31
10198956535138CARDINAL HEALTHCardinal Health 200, LLCOJH2026-07-31