FDA.reportPublic FDA data

Sklar

Primary DI
10649111161889
Brand
Sklar
Company
SKLAR CORPORATION
Model
40-7154
Device description
WILLIGER ELEV 7MM 6.75 INCHES
Published
2019-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10649111161889PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911116188910649111161889

GMDN Terms#

Term, Definition table
TermDefinition
Neurosurgical bone flap elevatorA hand-held, manually-operated surgical instrument used to pry up, lift, and position a bone flap in a neurosurgical procedure upon the skull. Also known as a bone flap elevator it is typically a one-piece instrument that consists of a robust, long, round-nosed, dull blade at the distal working end and a handle at the proximal end. It is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
10649111183386Sklar40-73122019-09-24
10649111183560Sklar40-73132019-09-24
10649111183713Sklar40-73142019-09-24
10649111183881Sklar40-73152019-09-24
10649111183997Sklar40-73162019-09-24
10649111184260Sklar40-73172019-09-24
10649111184420Sklar40-73182019-09-24
10649111187896Sklar40-73402019-09-24
10649111087431Sklar Instruments96-01922025-11-12
10649111225369Sklar Instruments96-10922025-11-12
10649111226281Sklar Instruments96-10972025-11-12
10649111226458Sklar Instruments96-10982025-11-12
10649111226762Sklar Instruments96-11002025-11-12
10649111226984Sklar Instruments96-11022025-11-12
10649111227370Sklar Instruments96-11052025-11-12
10649111228056Sklar Instruments96-11102025-11-12
10649111228919Sklar Instruments96-11152025-11-12
10649111229817Sklar Instruments96-11202025-11-12

Other Devices Sharing Product Codes#

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
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