FDA.reportPublic FDA data

FASSIER-DUVAL TELESCOPIC IM SYSTEM

Primary DI
07540194014245
Brand
FASSIER-DUVAL TELESCOPIC IM SYSTEM
Company
Orthopediatrics Canada ULC
Model
FC-WHL100
Catalog number
FC-WHL100
Device description
CUTTING WHEEL FOR THE FEMALE COMPONENT CUTTER
Published
2023-11-16
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
HSOSAW
HXZCUTTER, WIRE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSOSawGeneral, Plastic Surgery1
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540194014245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194014245075401940142457540194014245

GMDN Terms#

Term, Definition table
TermDefinition
Metal-cutting burA rotary cutting device consisting of a shaft and a cutting working end made of hard materials (e.g., high-grade steel, carbide, diamond) which is designed to fit into an appropriate powered handpiece that provides the rotation, and is intended for cutting hard metal, typically a device/implant during orthopaedic surgery. This is a single-use 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
DM exempt
true
Premarket exempt
true
Lot or batch
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
00810207784005Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784012Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810207784029Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHXZ2026-07-07
00810189450783Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450790Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450806Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450813Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450820Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450837Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450844Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450851Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450868Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450875Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450882Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450899Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450905Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450912Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450929Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450936Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450943Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450950Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450967Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450974Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189450981Surgical DesignSurgical Design, Inc.HSO2026-06-06
00810189451087Surgical DesignSurgical Design, Inc.HSO2026-06-06
20757770457766Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457773Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
20757770457780Bausch + LombBausch & Lomb IncorporatedHXZ2026-04-30
00810055254040Surgical DesignSurgical Design, Inc.HSO2026-04-21
08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09