FDA.report

American Medicals

Primary DI
B35607423240
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-21
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
GDNKnife, Amputation

Product Code Classifications

CodeDeviceSpecialtyClass
GDNKnife, AmputationGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B35607423240PrimaryHIBCC0

GMDN Terms

TermDefinition
Autopsy knifeA hand-held manual surgical instrument with a handle and a heavy single-edged blade, of various shapes and sizes, used during an autopsy to cut open and dissect a cadaver. It is typically a one-piece instrument made of high-grade stainless steel; it may employ synthetic or wood material as part of the handle. This is a reusable 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

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B356KE292350American Medicals12025-08-15
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B356KE312070American Medicals12025-08-15
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00190776210786AvalignAVALIGN TECHNOLOGIES, INC.GDN2021-11-03
00190660205805Ambler SurgicalAMBLER SURGICAL CORP.GDN2021-01-04
00190660205812Ambler SurgicalAMBLER SURGICAL CORP.GDN2021-01-04