FDA.reportPublic FDA data

LAZIC

Primary DI
04250603738053
Brand
LAZIC
Company
Peter Lazic GmbH
Model
70.220.19
Catalog number
70.220.19
Device description
"BRAIN SPATULAS AACHEN PATTERN WIDTH 19 / 20 MM, LENGHT 200 MM / 8"" "
Published
2021-04-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GAFSpatula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250603738053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250603738053042506037380534250603738053

GMDN Terms#

Term, Definition table
TermDefinition
Brain spatulaA hand-held manual surgical instrument designed to manipulate neural tissue or to remove a material from a neural surface or vessel during brain surgery. It is typically made of high-grade stainless steel and consists of a handle proximally and a broad flat blunt blade (no sharp edges) that can be slightly curved or have various angles at the distal tip, or it can be double-ended. 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
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250603753148LAZIC70.149.242026-08-25
04250603753155LAZIC70.149.112026-08-25
04250603753162LAZIC70.149.122026-08-25
04250603753179LAZIC70.149.132026-08-25
04250603753186LAZIC70.149.212026-08-25
04250603753193LAZIC70.149.232026-08-25
04250603739685LAZIC35.44035.4402019-08-20
04250603739692LAZIC35.44135.4412019-08-20
04250603739708LAZIC35.44235.4422019-08-20
04250603753063LAZIC46.957.042026-03-25
04250603753070LAZIC46.953.042026-03-25
04250603753087LAZIC46.952.042026-03-25
04250603753094LAZIC46.955.022026-03-25
04250603753100LAZIC46.954.022026-03-25
04250603753117LAZIC46.975.042026-03-25
04250603753124LAZIC46.970.042026-03-25
04250603753131LAZIC46.951.042026-03-25
04250603748502LAZIC46.941.042024-11-20
04250603748526LAZIC46.944.022024-11-20
04250603749271LAZIC46.942.042024-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462902675evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902682evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902750evonosevonos GmbH & Co. KGGAF2026-08-21
04054462917495evonosevonos GmbH & Co. KGGAF2026-08-19
04054462901548evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902699evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902705evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902712evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902729evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902736evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902743evonosevonos GmbH & Co. KGGAF2026-08-18
B382SD571001EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571002EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571004EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
08961104622548Spatula 6mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622555Spatula 8.0 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622562Spatula 10 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
00840343727352GEN2SURGIX MEDICAL LLCGAF2026-04-16
10889950147624Hu-FriedyHU-FRIEDY MFG. CO., LLCGAF2026-02-24
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07
B382SD9150391000Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391050Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150391060Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD9150471120Surgical DirectSurgical Direct, Inc.GAF2025-12-29
B382SD915095250Surgical DirectSurgical Direct, Inc.GAF2025-12-29
08800075627766OSUNG MNDOSUNG MND Co., Ltd.GAF2025-11-03
00810158217652PRINCETONPrinceton Medical Group, Inc.GAF2025-10-17