FDA.report

American Medicals

Primary DI
B35670741040
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-08
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
GACRasp, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GACRasp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B35670741040PrimaryHIBCC0

GMDN Terms

TermDefinition
Intrauterine curette, manualA heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. 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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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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10705034577074N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577081N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577104N/ADEPUY SPINE, LLCGAC2026-02-05
10705034577555N/ADEPUY SPINE, LLCGAC2026-02-05
03662663083577ActivLHighridge Medical, LLCGAC2026-02-03
00842078102275Omni PlatingEXTREMITY MEDICAL, LLCGAC2026-01-21
00842078102329Omni PlatingEXTREMITY MEDICAL, LLCGAC2026-01-21
00810207783558Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783565Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783572Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783589Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783596Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
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00810207783619Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783626Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783633Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783640Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783657Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783664Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00810207783671Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGAC2025-11-24
00190776411367MillenniumAvalign Technologies, Inc.GAC2025-09-22
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00190776409821MillenniumAvalign Technologies, Inc.GAC2025-09-08
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B356FF131050American MedicalsAmerican MedicalsGAC2025-08-16
00190776406875MillenniumAvalign Technologies, Inc.GAC2025-07-24
00190776406578MillenniumAvalign Technologies, Inc.GAC2025-07-22
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