FDA.reportPublic FDA data

Alira Medical Devices

Primary DI
G767SCAL1330
Brand
Alira Medical Devices
Company
Alira Medical Devices, LLC
Model
SCA-L133
Catalog number
SCA-L133
Device description
Scalpel Handle #3 14.5cm With Round Handle
Published
2025-09-26
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
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G767SCAL1330PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel, single-useA hand-held, manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The blade is typically made of high-grade stainless steel alloy or carbon steel and the handle is often made of plastic. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 818-614-4592info@alirameddevices.com

Regulatory Flags#

DUNS number
112837961
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G767AAA01510Alira Medical DevicesAAA-0151AAA-01512025-09-26
G767AAA03960Alira Medical DevicesAAA-0396AAA-03962025-09-26
G767ATSCA010T0Alira Medical DevicesATSC-A010TATSC-A010T2025-09-26
G767C024120Alira Medical DevicesC02-412C02-4122025-09-26
G767C024300Alira Medical DevicesC02-430C02-4302025-09-26
G767C025200Alira Medical DevicesC02-520C02-5202025-09-26
G767C02G4240Alira Medical DevicesC02G-424C02G-4242025-09-26
G767C171080Alira Medical DevicesC17-108C17-1082025-09-26
G767C174090Alira Medical DevicesC17-409C17-4092025-09-26
G767C174230Alira Medical DevicesC17-423C17-4232025-09-26
G767C174240Alira Medical DevicesC17-424C17-4242025-09-26
G767C174300Alira Medical DevicesC17-430C17-4302025-09-26
G767C17526E0Alira Medical DevicesC17-526EC17-526E2025-09-26
G767C175330Alira Medical DevicesC17-533C17-5332025-09-26
G767C214240Alira Medical DevicesC21-424C21-4242025-09-26
G767C21532A0Alira Medical DevicesC21-532AC21-532A2025-09-26
G767C21533A0Alira Medical DevicesC21-533AC21-533A2025-09-26
G767CBW1010Alira Medical DevicesCBW-101CBW-1012025-09-26
G767CCB1010Alira Medical DevicesCCB-101CCB-1012025-09-26
G767CCB1020Alira Medical DevicesCCB-102CCB-1022025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275563Intrace USAPILOTIS TECH LLCGDZ2026-07-03
00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255726Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255788Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255801Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255825Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255863Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256105Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256112Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256129Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256136Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256150Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256174Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256181Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256198Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256204Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810189455139Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00190776421847MillenniumAvalign Technologies, Inc.GDZ2026-06-25
00810055257348Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257355Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257362Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257379Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257386Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257850Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00190776421533MillenniumAvalign Technologies, Inc.GDZ2026-05-05
00190776419769MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419776MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419783MillenniumAvalign Technologies, Inc.GDZ2026-04-15