FDA.reportPublic FDA data

SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM

Primary DI
07540194012012
Brand
SIMPLE LOCKING INTRAMEDULLARY (SLIM) SYSTEM
Company
Orthopediatrics Canada ULC
Model
GIN-AOH100
Catalog number
GIN-AOH100
Device description
AO HANDLE
Published
2021-03-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540194012012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540194012012075401940120127540194012012

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

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
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

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