FDA.reportPublic FDA data

Symmetry Karlin™ XL Magnum

Primary DI
00887482015438
Brand
Symmetry Karlin™ XL Magnum
Company
ASPEN SURGICAL PRODUCTS, INC.
Model
46-3245
Catalog number
46-3245
Device description
Symmetry® Karlin Elevator, Xl Magnum Cobb, 30 mm Blade Width, 13 1/2 in
Published
2022-09-20
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
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887482015438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887482015438008874820154388874820154380887482015438

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length13.5Inch
Width30Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 888-364-7004customerservice@symmetrysurgical.com

Regulatory Flags#

DUNS number
027680821
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840113233762Bovie Derm 1022026-05-11
00607151010263BovieA1250SA1250S2018-02-23
00840113244232ValleylabE15594E155942026-05-04
00840113244249ValleylabE15596E155962026-05-04
00840113244256ValleylabE15604E156042026-05-04
00840113244263ValleylabE15606E156062026-05-04
00840113244270ValleylabE15614E156142026-05-04
00840113244287ValleylabE15616E156162026-05-04
00840113244294ValleylabE15624E156242026-05-04
00840113244300ValleylabE15626E156262026-05-04
00840113244317ValleylabE15644E156442026-05-04
00840113244324ValleylabE15646E156462026-05-04
00840113244331ValleylabE16512 E16512 2026-05-04
00840113244348ValleylabE16514E165142026-05-04
00887482188873BovieA23502024-09-27
00887482188897BovieA33502024-09-27
00887482181324BovieIDS-2102024-08-26
00887482181508BovieIDS-3102024-08-26
00887482182536BovieA9422024-08-26
00887482182550BovieA9522024-08-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G4251902480My MedicalMy Medical Store LLCGEG2026-05-04
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10381780503606Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2020-10-01
10649111225628SklarSKLAR CORPORATIONGEG2019-08-02
10649111452826SklarSKLAR CORPORATIONGEG2019-05-13
10381780495888Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-10-24
10381780509523Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-10-23
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10381780401254Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401261Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401278Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401285Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780401292Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02
10381780409779Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGEG2018-05-02