FDA.report

LAZIC

Primary DI
04250603701774
Brand
LAZIC
Company
Peter Lazic GmbH
Model
45.262
Catalog number
45.262
Device description
L-Aneurysm Clip STANDARD, Titanium, temporary, slightly curved 11mm
Published
2015-12-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HCHClip, Aneurysm

Product Code Classifications

CodeDeviceSpecialtyClass
HCHClip, AneurysmNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250603701774PrimaryGS10

GMDN Terms

TermDefinition
Aneurysm clip, non-sterileA non-sterile, metallic device intended to be permanently implanted around the neck of an aneurysm (a balloon-like sac formed on a blood vessel) for occlusion, to prevent it from bleeding or bursting and to isolate it from the rest of the vessel. The device is typically an alpha-shaped coil spring, with blades that open like jaws, that comes with a dedicated applier for application to the aneurysm. The device is available in a variety of sizes and its blades may be straight or curved. It is typically used to treat intracranial aneurysms; it may also be used to prevent bleeding from small blood vessels.

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
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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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04250603753032LAZIC65.540 L65.540 L2025-08-05
04250603737728LAZIC64.302.1164.302.112025-07-29
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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
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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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04250603714835LAZICPeter Lazic GmbHHCH2025-08-07
04250603733911LAZICPeter Lazic GmbHHCH2025-08-07
04250603753018LAZICPeter Lazic GmbHHCH2025-06-30
04250603727194LAZICPeter Lazic GmbHHCH2025-06-16
04250603734031LAZICPeter Lazic GmbHHCH2025-06-16
04250603733980LAZICPeter Lazic GmbHHCH2025-05-13
04946329416725SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416732SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416749SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
04946329416756SUGITA TITANIUM ANEURYSM CLIP IIMIZUHO CORPORATIONHCH2025-04-25
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