FDA.reportPublic FDA data

LAZIC

Primary DI
04250603713487
Brand
LAZIC
Company
Peter Lazic GmbH
Model
46.268
Catalog number
46.268
Device description
DIAMOND KNIFE; LANCE BLADE 60°; STRAIGHT BLADE LENGHT 3MM; BLADE WIDTH 1MM; SHARPENED ONE SIDE
Published
2021-05-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMFKnife, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250603713487PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250603713487042506037134874250603713487

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, reusableA hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. 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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250603753049LAZIC65.1002 TL2025-08-26
04250603709527LAZICS.65.776 TS.65.776 T2025-08-07
04250603714835LAZICS.65.777 TS.65.777 T2025-08-07
04250603733911LAZICS.65.886 TS.65.886 T2025-08-07
04250603753032LAZIC65.540 L65.540 L2025-08-05
04250603737728LAZIC64.302.1164.302.112025-07-29
04250603753018LAZICS.65.330 TS.65.330 T2025-06-30
04250603727194LAZICS.65.320 TS.65.320 T2025-06-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08681506800343SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2026-01-26
08681506800350SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2026-01-24
00848530100162Disposable Wire-Guided Scapel for Central Venous CannulationSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
00848530100179GuideBlade Sample KitSUNSET HEALTHCARE SOLUTIONS, INC.EMF2025-12-09
08681506801302SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-09
08681506801227SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETIEMF2025-12-08
04046826114374Medicon TrayMedicon eG. Chirurgiemechaniker-GenossenschaftEMF2025-12-01
00190776404604MillenniumAvalign Technologies, Inc.EMF2025-07-10
00190776403058MillenniumAvalign Technologies, Inc.EMF2025-07-01
00190776403201MillenniumAvalign Technologies, Inc.EMF2025-07-01
08717903490280Humeca Silver knifeHumeca B.V.EMF2025-05-20
08717903490297Humeca Humby knifeHumeca B.V.EMF2025-05-20
08717903490303Humeca Cobbett knifeHumeca B.V.EMF2025-05-20
08717903490310Humeca Watson knifeHumeca B.V.EMF2025-05-20
08717903490327Humeca Humby long knifeHumeca B.V.EMF2025-05-20
00190776397616MillenniumAvalign Technologies, Inc.EMF2025-05-16
00190776393137MillenniumAvalign Technologies, Inc.EMF2025-05-05
04049047000143GimmiGimmi GmbHEMF2025-04-16
04049047000297GimmiGimmi GmbHEMF2025-04-16
04049047000303GimmiGimmi GmbHEMF2025-04-16
04049047000358GimmiGimmi GmbHEMF2025-04-16
04049047000365GimmiGimmi GmbHEMF2025-04-16
04049047000402GimmiGimmi GmbHEMF2025-04-16
04049047000426GimmiGimmi GmbHEMF2025-04-16
04049047000457GimmiGimmi GmbHEMF2025-04-16
04049047000549GimmiGimmi GmbHEMF2025-04-16
04049047000853GimmiGimmi GmbHEMF2025-04-16
04049047000860GimmiGimmi GmbHEMF2025-04-16
04049047000877GimmiGimmi GmbHEMF2025-04-16
04049047000884GimmiGimmi GmbHEMF2025-04-16