FDA.reportPublic FDA data

American Medicals

Primary DI
B356111MDCM6351S0
Brand
American Medicals
Company
American Medicals
Model
1
Published
2023-01-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B356111MDCM6351S1PackageHIBCC25In Commercial Distribution
B356111MDCM6351S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Podiatric bur, single-useA rotary abrasive device typically used by a podiatrist intended to debride excrescences and treat conditions such as heavy toenails and/or plantar calluses. It consists of a well-differentiated head of various shapes (e.g., cone, cylinder, inverted cone, pear) made of hard materials (e.g., diamond, metal carbide), and a tapered, notched or elongated proximal end intended to fit into an appropriate powered handpiece (not included); it may be composed of two separate pieces. This is a single-use device.

Regulatory Flags#

DUNS number
109909627
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B356111PL87514ST0steriSTAT12026-10-20
B356111OP918ST0American Medicals12022-12-11
B35665124160American Medicals12026-09-25
B356KD905230American Medicals12026-09-25
B356KD910090American Medicals12026-09-25
B356FF192040American Medicals12022-09-26
B35645724070American Medicals12022-09-09
B356FF701020American Medicals12026-07-14
B356JB405140American Medicals12026-07-06
B356BK211110American Medicals12026-05-29
B356KE392100American Medicals12026-05-29
B356KE396100American Medicals12026-05-29
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613053232KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613054222KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613167298KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613205525KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613266892KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268599KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268612KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268650KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226021289G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226021291G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226031156AU1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226017146A11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226046554A11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001998KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613002322KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613266915KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613267578KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613272435KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613273418KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31