FDA.reportPublic FDA data

LAZIC

Primary DI
04250603735076
Brand
LAZIC
Company
Peter Lazic GmbH
Model
46.365.02
Catalog number
46.365.02
Device description
"RHOTON ELEVATOR NO. 5 BLADE WIDTH 2,6 MM, ANGLED WORKING/ TOTAL LENGTH 92/190 MM / 7 1/2"" "
Published
2020-08-05
Public version status
New
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
04250603735076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250603735076042506037350764250603735076

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

Contacts#

Phone, Email table
PhoneEmail
1 844 261 3271support@peterlazic.com

Regulatory Flags#

DUNS number
327681359
Device count
1
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
04250603753063LAZIC46.957.042026-03-25
04250603753070LAZIC46.953.042026-03-25
04250603753087LAZIC46.952.042026-03-25
04250603753094LAZIC46.955.022026-03-25
04250603753100LAZIC46.954.022026-03-25
04250603753117LAZIC46.975.042026-03-25
04250603753124LAZIC46.970.042026-03-25
04250603753131LAZIC46.951.042026-03-25
04250603748502LAZIC46.941.042024-11-20
04250603748526LAZIC46.944.022024-11-20
04250603749271LAZIC46.942.042024-11-20
04250603749288LAZIC46.943.042024-11-20
04250603749295LAZIC46.945.022024-11-20
04250603749301LAZIC46.947.042024-11-20
04250603749318LAZIC46.960.042024-11-20
04250603749325LAZIC46.965.042024-11-20
04250603703679LAZIC65.18265.1822025-10-30
04250603703778LAZIC65.21265.2122025-10-30
04250603703860LAZIC65.22665.2262025-10-30
04250603753025LAZIC45.442 S2025-10-01

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
10649111452826SklarSKLAR CORPORATIONGEG2019-05-13
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