FDA.reportPublic FDA data

American Medicals

Primary DI
B3561116583ST0
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-06
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
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B3561116583ST1PackageHIBCC25In Commercial Distribution
B3561116583ST0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, single-useA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures, typically during ear/nose/throat (ENT) surgery; it is not intended for insertion through an endoscope, nor into the eye and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a single-use device.

Regulatory Flags#

DUNS number
109909627
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
B356ED470050American Medicals12026-04-07
B356JD259280American Medicals12026-03-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433178MillenniumAvalign Technologies, Inc.GEN2026-10-01
B382SD8160490Surgical DirectSurgical Direct, Inc.GEN2026-09-30
00190776432829MillenniumAvalign Technologies, Inc.GEN2026-09-29
00190776432898MillenniumAvalign Technologies, Inc.GEN2026-09-29
B382SD4937851340Surgical DirectSurgical Direct, Inc.GEN2026-09-29
00190776432522MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432553MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432560MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432577MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432744MillenniumAvalign Technologies, Inc.GEN2026-09-28
00724995268985Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995268992Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269005Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269012Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269029Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269036Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269043Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
B35665124160American MedicalsAmerican MedicalsGEN2026-09-25
00724995266752Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-24
00190776431273MillenniumAvalign Technologies, Inc.GEN2026-09-22
00190776432096MillenniumAvalign Technologies, Inc.GEN2026-09-22
04058749037364NAFehling Instruments GmbH & Co. KGGEN2026-09-21
00190776431006MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776431013MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776429034MillenniumAvalign Technologies, Inc.GEN2026-09-04
00190776429058MillenniumAvalign Technologies, Inc.GEN2026-09-04
04058749001280NAFehling Instruments GmbH & Co. KGGEN2026-09-04