FDA.reportPublic FDA data

Needle Holder TC

Primary DI
G390MM6000570
Brand
Needle Holder TC
Company
NTZ SURGICAL COMPANY
Model
MM-600-057
Catalog number
MM-600-057
Published
2022-12-30
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
G390MM6000570PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645764262
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G390336542K0NTZ Surgical336-542K336-542K2023-06-30
G390336543K0NTZ Surgical336-543K336-543K2023-06-30
G3903822010NTZ Surgical382-201382-2012023-06-30
G3903822020NTZ Surgical382-202382-2022023-06-30
G390MM600001L0Sponge ForcepMM-600-001LMM-600-001L2022-12-30
G390MM600001M0Sponge ForcepMM-600-001MMM-600-001M2022-12-30
G390MM600001XS0Sponge ForcepMM-600-001XSMM-600-001XS2022-12-30
G390MM600003L0Duval ForcepMM-600-003LMM-600-003L2022-12-30
G390MM600003S0Duval ForcepMM-600-003SMM-600-003S2022-12-30
G390MM6000450Debakey Dissector Forcep 45 DegreeMM-600-045MM-600-0452022-12-30
G390MM6000750Debakey Dissector Forcep 75 DegreeMM-600-075MM-600-0752022-12-30
G390MM6000900Debakey Dissector Forcep 90 DegreeMM-600-090MM-600-0902022-12-30
G390MM600334LC0Debakey Forcep Long CurveMM-600-334LCMM-600-334LC2022-12-30
G390MM600334SC0Debakey Forcep Small CurveMM-600-334SCMM-600-334SC2022-12-30
G390MM6003450Debakey ForcepMM-600-345MM-600-3452022-12-30
G390MM600345S0Debakey Forcep SmallMM-600-345SMM-600-345S2022-12-30
G390MM6006230Yankauer Suction MM-600-623MM-600-6232022-12-30
G390MM600625Yankauer Suction MM-600-625MM-600-6252022-12-30
G390MM4000010Needle HolderMM-400-001MM-400-0012022-12-10
G390MM5000010Duval ForcepMM-500-001MM-500-0012022-12-10

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Primary DI, Brand, Company table
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