FDA.report

LAZIC

Primary DI
04250603713630
Brand
LAZIC
Company
Peter Lazic GmbH
Model
46.308
Catalog number
46.308
Device description
RHOTON ELEVATOR 2 MM; 15° ANGLED; NO. 8
Published
2020-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEGElevator, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GEGElevator, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250603713630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250603713630042506037136304250603713630

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1 844 261 3271support@peterlazic.com

Regulatory Flags

DUNS number
327681359
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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04250603734031LAZICS.65.319 TS.65.319 T2025-06-16
04250603733980LAZICS.65.306 TS.65.306 T2025-05-13
04250603749240LAZIC62.55862.5582025-04-15
04250603749257LAZIC62.54862.5482025-04-15
04250603748502LAZIC46.941.042024-11-20
04250603748526LAZIC46.944.022024-11-20
04250603748571LAZIC70.149.142024-11-20
04250603748588LAZIC70.149.222024-11-20
04250603748595LAZIC74.355.002024-11-20
04250603748601LAZIC74.358.012024-11-20
04250603748618LAZIC74.332.452024-11-20
04250603748625LAZIC74.332.002024-11-20

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