FDA.reportPublic FDA data

LAZIC

Primary DI
04250603711537
Brand
LAZIC
Company
Peter Lazic GmbH
Model
65.027
Catalog number
65.027
Device description
Storage tray for clips applier and Instruments; made out of PPSU, for steam sterilization up to 3 bar (143°C/289°F)
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
LRPTray, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250603711537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250603711537042506037115374250603711537

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument container systemA combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable surgical instruments between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers for the transportation of sterile surgical instruments from the central sterilization station to the operating room, and the reverse for soiled instruments to be decontaminated and sterilized; the soiled-instrument containers frequently including pre-soaking capabilities. Smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters. 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

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Primary DI, Brand, Company table
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