FASSIER-DUVAL TELESCOPIC IM SYSTEM

Primary DI
07540194000415
Brand
FASSIER-DUVAL TELESCOPIC IM SYSTEM
Company
Orthopediatrics Canada ULC
Model
FD-048(SPS)-SS
Catalog number
FD-048(SPS)-SS
Device description
Short Tibial/Humeral Nail Assy Ø4.8mm x 404mm
Published
2016-10-20
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
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020885000
K041393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020885000FASSIRE-DUVAL TELESCOPIC IM SYSTEMPega Medical, Inc.2003-02-06HSB
K041393000FASSIER-DUVAL TELSCOPIC IM SYSTEMPega Medical, Inc.2004-08-17HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540194000415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194000415075401940004157540194000415

GMDN Terms#

Term, Definition table
TermDefinition
Humerus nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the humerus, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length404Millimeter
Outer Diameter4.8Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep at room temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
243298854
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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

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Primary DI, Brand, Company table
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