FDA.report

American Medicals

Primary DI
B3564511432000
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LRWScissors, General, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B3564511432000PrimaryHIBCC0

GMDN Terms

TermDefinition
Ophthalmic strabismus scissorsA hand-held, manual, ophthalmic surgical instrument intended to be used to cut the muscles of the eye during strabismus surgery. It comprises two pivoted blades that usually have finger and thumb ring-handles, and which cut with a shearing action (i.e., the fine blades cut when the sharpened edges pass one another as they are closed). It is typically made of metal and is available in various designs and sizes. It is not intended for intraocular surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Microwave Radiation

Regulatory Flags

DUNS number
109909627
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
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
B356KD932040American Medicals12025-09-18
B356KD932070American Medicals12025-09-18
B356KE334280American Medicals12025-09-15
B356KJ522130American Medicals12025-09-12
B356FF131030American Medicals12025-08-16
B356FF131050American Medicals12025-08-16
B356KE292350American Medicals12025-08-15
B356KE295040American Medicals12025-08-15
B356KE296030American Medicals12025-08-15
B356KE312070American Medicals12025-08-15
B356KE328060American Medicals12025-08-15

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00810055256211Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256235Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256242Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055256259Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258604Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258611Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258628Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258635Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258642Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258659Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258666Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258673Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258680Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258697Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258703Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258710Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810055258727Surgical DesignSurgical Design, Inc.LRW2026-05-26
00810220800218Adler Instrument CompanyAdler, Inc.LRW2026-05-26
00810220800225Adler Instrument CompanyAdler, Inc.LRW2026-05-26
00810220800232Adler Instrument CompanyAdler, Inc.LRW2026-05-26
00810055250455Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250462Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250479Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250486Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250493Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250509Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250516Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250523Surgical DesignSurgical Design, Inc.LRW2026-05-25
00810055250554Surgical DesignSurgical Design, Inc.LRW2026-05-25