FDA.reportPublic FDA data

ELITE MEDICAL INSTRUMENTATION

Primary DI
G569EMIS1HS0150
Brand
ELITE MEDICAL INSTRUMENTATION
Company
ELITE MEDICAL INSTRUMENTATION
Model
EMI-S1HS-015
Catalog number
EMI-S1HS-015 RETRACTOR
Device description
"Alm Retractor, 4"", Sharp"
Published
2024-01-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FFORetractor, Self-Retaining

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G569EMIS1HS0150PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length4Inch

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
00810238290049PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
00850088713862PRINCETONPrinceton Medical Group, Inc.FFO2026-09-22
04049047074694GimmiGimmi GmbHFFO2026-08-14
B382SD921405170Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD93415040Surgical DirectSurgical Direct, Inc.FFO2026-08-07
B382SD459000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460350Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD460360Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467000Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467010Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467020Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467030Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467040Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD467050Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD48250Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493680Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493690Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD493770Surgical DirectSurgical Direct, Inc.FFO2026-08-03
B382SD6213120Surgical DirectSurgical Direct, Inc.FFO2026-08-03
00190776407483MillenniumAvalign Technologies, Inc.FFO2026-07-31
B382SD14174550Surgical DirectSurgical Direct, Inc.FFO2026-07-31
B382SD90712216T0Surgical DirectSurgical Direct, Inc.FFO2026-07-29
B382SD907581320Surgical DirectSurgical Direct, Inc.FFO2026-07-24
B382SD9075041030Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530128T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907530129T0Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907573330Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9075800910Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD907580150Surgical DirectSurgical Direct, Inc.FFO2026-07-17
B382SD9076231100Surgical DirectSurgical Direct, Inc.FFO2026-07-17