FDA.reportPublic FDA data

Alira Medical Devices

Primary DI
G767S1380160
Brand
Alira Medical Devices
Company
Alira Medical Devices, LLC
Model
S138-016
Catalog number
S138-016
Device description
GUBISCH FOMON NASAL RASP
Published
2025-09-25
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
HTRRasp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G767S1380160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periodontal file/rasp, manualA hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. This is a reusable 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
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00199150082858Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
00199150082865Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
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00199150082889Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTR2026-07-04
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