FDA.report

American Medicals

Primary DI
B35613240140
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-28
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
HRQHemostat

Product Code Classifications

CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B35613240140PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); 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 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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04059453072740Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRQ2026-01-13
04059453072788Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRQ2026-01-13
00810207781929Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781936Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781943Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781950Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781967Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781974Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781981Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781998Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782001Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782018Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782025Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782032Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782049Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782056Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782063Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782117Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782124Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00840183531133BR Surgical, LLCBR Surgical, LLCHRQ2025-09-29
05010058178885InstrapacROBINSON HEALTHCARE LIMITEDHRQ2025-09-11
05010058182554InstrapacROBINSON HEALTHCARE LIMITEDHRQ2025-09-11
04059453071279Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRQ2025-09-09
00840183530631BR Surgical, LLCBR Surgical, LLCHRQ2025-08-22
00840183529567BR Surgical, LLCBR Surgical, LLCHRQ2025-07-16
00840183529574BR Surgical, LLCBR Surgical, LLCHRQ2025-07-16
00840183529628BR Surgical, LLCBR Surgical, LLCHRQ2025-07-16
00840183529635BR Surgical, LLCBR Surgical, LLCHRQ2025-07-16
05010058179080InstrapacROBINSON HEALTHCARE LIMITEDHRQ2025-06-23
05010058182363InstrapacROBINSON HEALTHCARE LIMITEDHRQ2025-06-23