FDA.reportPublic FDA data

American Medicals

Primary DI
B356FF115000
Brand
American Medicals
Company
American Medicals
Model
1
Published
2025-05-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B356FF115000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Endaural surgical curette, reusableA slender, hand-held, manual surgical instrument designed for procedures during middle ear surgery (e.g., removal of the superior bony rim), and may in addition be used for scraping within the ear canal (e.g., removing wax). The instrument has a serrated or blunt loop, or hook, at its distal end that may be straight, slightly curved, or angled; it is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Microwave Radiation

Regulatory Flags#

DUNS number
109909627
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B35675400020American Medicals12026-05-20
B35675440110American Medicals12026-05-20
B356BH414050American Medicals12026-05-06
B356KB074090American Medicals12026-05-06
B356KF251020American Medicals12026-04-15
B356KF251040American Medicals12026-04-15
B356ED469970American Medicals12026-04-07
B356ED470040American Medicals12026-04-07
B356ED470050American Medicals12026-04-07
B356JD259280American Medicals12026-03-09
B356JB543320American Medicals12026-02-26
B356JB641170American Medicals12026-02-06
B356DF370170American Medicals12026-01-30
B356BK905180American Medicals12026-01-27
B356FH454070American Medical12025-12-10
B356FH455060American Medicals12025-12-10
B356ED107160American Medicals12025-12-03
B356JB536280American Medicals12025-11-25
B356BK211150American Medicals12025-11-10
B356DF410180American Medicals12025-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B35675400020American MedicalsAmerican MedicalsGAC2026-05-20
05055445940881SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940898SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940904SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940911SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445940928SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973001SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973018SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973025SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973032SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
05055445973049SurtexSURTEX INSTRUMENTS LTD.GAC2026-05-12
00190776421014MillenniumAvalign Technologies, Inc.GAC2026-04-30
B356ED469970American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470040American MedicalsAmerican MedicalsGAC2026-04-07
B356ED470050American MedicalsAmerican MedicalsGAC2026-04-07
B356FF114000American MedicalsAmerican MedicalsGAC2025-05-27
B356FF115020American MedicalsAmerican MedicalsGAC2025-05-27
10888277374324MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10888277382992MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-02-14
10080196382989MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10080196384983MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277374515MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377004MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377011MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277377509MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277381971MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277382442MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384286MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277384415MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29
10888277385863MEDLINEMEDLINE INDUSTRIES, INC.GAC2025-01-29