FDA.report

LAZIC

Primary DI
04250603720522
Brand
LAZIC
Company
Peter Lazic GmbH
Model
64.650.18
Catalog number
64.650.18
Device description
applying forceps for DeBakey Atrauma Bulldog Clamps, length 250 mm curved
Published
2020-09-22
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
GDOApplier, Surgical, Clip

Product Code Classifications

CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250603720522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250603720522042506037205224250603720522

GMDN Terms

TermDefinition
Open-surgery ligation clip applierA hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization.

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04250603753049LAZIC65.1002 TL2025-08-26
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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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