FDA.reportPublic FDA data

LAZIC

Primary DI
04250603738732
Brand
LAZIC
Company
Peter Lazic GmbH
Model
70.580.00
Catalog number
70.580.00
Device description
"SPREADER FOR SPECULA AFTER LANDOLT 70.581.01 TO 70.581.04 TOTAL LENGTH 210 MM / 8 1/4"" "
Published
2020-12-22
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
KAGHolder, Speculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAGHolder, Speculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250603738732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250603738732042506037387324250603738732

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. 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
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
04250603749288LAZIC46.943.042024-11-20
04250603749295LAZIC46.945.022024-11-20
04250603749301LAZIC46.947.042024-11-20
04250603749318LAZIC46.960.042024-11-20
04250603749325LAZIC46.965.042024-11-20
04250603703679LAZIC65.18265.1822025-10-30
04250603703778LAZIC65.21265.2122025-10-30
04250603703860LAZIC65.22665.2262025-10-30
04250603753025LAZIC45.442 S2025-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250603738084LAZICPeter Lazic GmbHKAG2020-12-22
04250603738718LAZICPeter Lazic GmbHKAG2020-12-22
04250603738725LAZICPeter Lazic GmbHKAG2020-12-22
04250603738749LAZICPeter Lazic GmbHKAG2020-12-22
04250603738756LAZICPeter Lazic GmbHKAG2020-12-22
04250603738763LAZICPeter Lazic GmbHKAG2020-12-22
04250603738770LAZICPeter Lazic GmbHKAG2020-12-22
04250603738787LAZICPeter Lazic GmbHKAG2020-12-22
04250603738794LAZICPeter Lazic GmbHKAG2020-12-22
04250603738800LAZICPeter Lazic GmbHKAG2020-12-22
04250603738817LAZICPeter Lazic GmbHKAG2020-12-22
04250603738824LAZICPeter Lazic GmbHKAG2020-12-22
04250603738831LAZICPeter Lazic GmbHKAG2020-12-22
04250603738848LAZICPeter Lazic GmbHKAG2020-12-22
04250603738855LAZICPeter Lazic GmbHKAG2020-12-22
04250603741688LAZICPeter Lazic GmbHKAG2020-12-22
04250603742036LAZICPeter Lazic GmbHKAG2020-12-22
04038653065417AESCULAPAesculap AGKAG2020-04-20
00614950022342ACEACE SURGICAL SUPPLY CO., INC.KAG2019-10-24
00614950022359ACEACE SURGICAL SUPPLY CO., INC.KAG2019-10-24
00614950022366ACEACE SURGICAL SUPPLY CO., INC.KAG2019-10-24