FDA.reportPublic FDA data

ELITE MEDICAL INSTRUMENTATION

Primary DI
G569EMIBM047R0
Brand
ELITE MEDICAL INSTRUMENTATION
Company
ELITE MEDICAL INSTRUMENTATION
Model
EMI-BM047R
Catalog number
EMI-BM047R NEEDLE HOLDER
Device description
"Needleholder, Ryder, TC, Delicate, Serrated, 10 1/2"""
Published
2024-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G569EMIBM047R0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10.5Inch

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
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
G569EMI3540020ELITE MEDICAL INSTRUMENTATIONEMI-354002EMI-354002 CLAMP2024-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7370TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7380TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7390TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7400TBS BASICSACME ENTERPRISE.FHQ2026-05-21
08961104621824Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621831Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621848Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621855Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621862Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621879Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621886Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621893Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621909Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621916Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621923Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621930Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621947Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621954Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621961Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621978Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621985Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621992Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
G45313110753150PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-05-06
G4254202900My MedicalMy Medical Store LLCFHQ2026-05-04
G4254203160My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209120My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209140My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209170My MedicalMy Medical Store LLCFHQ2026-02-17
G45313110845130PEAK MEDICALPeak Medical Distribution Inc.FHQ2023-07-03
G25004025180Tungsten Carbide Debakey Needle Holder 18cmN S SURGICAL COMPANYFHQ2023-01-27