FDA.report

American Medicals

Primary DI
B356JF600130
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-29
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
HRRScissors, Orthopedic, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
HRRScissors, Orthopedic, SurgicalOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B356JF600130PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, single-useA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device.

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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04059453049223Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2026-03-02
00810207783954Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783961Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783978Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783985Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
04059453054517Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2025-08-28
00757770505784Bausch + LombBausch & Lomb IncorporatedHRR2025-08-08
00194613061821MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613096328MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114121MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114671MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114688MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613115135MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613120092MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
B35675470110American MedicalsAmerican MedicalsHRR2025-06-30
B35675475110American MedicalsAmerican MedicalsHRR2025-06-25
00194613096311MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613096342MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613115142MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00846338005634Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005641Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005658Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005665Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005672Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338002237Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338003111Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338005214Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338005238Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338006815Bone CuretteELLIQUENCE, LLCHRR2025-01-09
00846338006822Bone CuretteELLIQUENCE, LLCHRR2025-01-09