FDA.reportPublic FDA data

ELITE MEDICAL INSTRUMENTATION

Primary DI
G569EMIFB412R0
Brand
ELITE MEDICAL INSTRUMENTATION
Company
ELITE MEDICAL INSTRUMENTATION
Model
EMI-FB412R
Catalog number
EMI-FB412R DEBAKEY FORCEPS
Device description
"Forceps, DeBakey, Cardiovascular, Atraumatic, Fine, Straight, 1.5mm, 8"" (Goldies)"
Published
2024-02-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G569EMIFB412R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
116733674
Device count
1
DM exempt
true
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G569EMIMD4700ELITE MEDICAL INSTRUMENTATIONEMI-MD470EMI-MD470 BABCOCK CLAMP2024-05-16
G569EMIBB074R0ELITE MEDICAL INSTRUMENTATIONEMI-BB074REMI-BB074R KNIFE HANDLE2024-03-22
G569EMIBB077R0ELITE MEDICAL INSTRUMENTATIONEMI-BB077REMI-BB077R KNIFE HANDLE2024-03-22
G569EMIBC547R0ELITE MEDICAL INSTRUMENTATIONEMI-BC547REMI-BC547R SCISSORS2024-03-22
G569EMIBC557R0ELITE MEDICAL INSTRUMENTATIONEMI-BC557REMI-BC557R SCISSORS2024-03-22
G569EMIBC648R0ELITE MEDICAL INSTRUMENTATIONEMI-BC648REMI-BC648R SCISSORS2024-03-22
G569EMIBC677R0ELITE MEDICAL INSTRUMENTATIONEMI-BC677REMI-BC677R SCISSORS2024-03-22
G569EMIBM004R0ELITE MEDICAL INSTRUMENTATIONEMI-BM004REMI-BM004R NEEDLE HOLDER2024-03-22
G569EMIBM047R0ELITE MEDICAL INSTRUMENTATIONEMI-BM047REMI-BM047R NEEDLE HOLDER2024-03-22
G569EMIBM055R0ELITE MEDICAL INSTRUMENTATIONEMI-BM055REMI-BM055R NEEDLE HOLDER2024-03-22
G569EMIBM058R0ELITE MEDICAL INSTRUMENTATIONEMI-BM058REMI-BM058R NEEDLE HOLDER2024-03-22
G569EMIBM066R0ELITE MEDICAL INSTRUMENTATIONEMI-BM066REMI-BM066R NEEDLE HOLDER2024-03-22
G569EMIBT470R0ELITE MEDICAL INSTRUMENTATIONEMI-BT470REMI-BT470R RETRACTOR2024-03-22
G569EMIBT611R0ELITE MEDICAL INSTRUMENTATIONEMI-BT611REMI-BT611R RETRACTOR2024-03-22
G569EMIBT614R0ELITE MEDICAL INSTRUMENTATIONEMI-BT614REMI-BT614R RETRACTOR2024-03-22
G569EMIBT756R0ELITE MEDICAL INSTRUMENTATIONEMI-BT756REMI-BT756R RETRACTOR2024-03-22
G569EMIBT763R0ELITE MEDICAL INSTRUMENTATIONEMI-BT763REMI-BT763R2024-03-22
G569EMIKTS1040ELITE MEDICAL INSTRUMENTATIONEMI-KTS1-04EMI-KTS1-04 SPECULUM2024-03-22
G569EMI3535350ELITE MEDICAL INSTRUMENTATIONEMI-35-3535EMI-35-3535 CLAMP2024-03-21
G569EMI3536310ELITE MEDICAL INSTRUMENTATIONEMI-353631EMI-353631 CLAMP2024-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395360MillenniumAvalign Technologies, Inc.HTD2026-07-14
B382SD906201100Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD906202100NC0Surgical DirectSurgical Direct, Inc.HTD2026-07-14
B382SD91705515T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD91705525T0Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9183761030Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184571000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
B382SD9184932000Surgical DirectSurgical Direct, Inc.HTD2026-07-13
00810158219960PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219977PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00810158219991PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850088713008PRINCETONPrinceton Medical Group, Inc.HTD2026-07-10
00850083275174Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275181Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275198Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275204Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275211Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275228Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275518Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275730Intrace USAPILOTIS TECH LLCHTD2026-07-03
00850083275747Intrace USAPILOTIS TECH LLCHTD2026-07-03
00190776421786MillenniumAvalign Technologies, Inc.HTD2026-06-24
00192896123502Stefan Bone Holding ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123519Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123526Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00192896123533Rochester Carmalt ForcepsSONTEC INSTRUMENTS, INC.HTD2026-06-24
00810158210837PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211100PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211117PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23
00810158211148PRINCETONPrinceton Medical Group, Inc.HTD2026-06-23