FDA.reportPublic FDA data

Laschal Surgical

Primary DI
B6597TCLCRWTL0
Brand
Laschal Surgical
Company
LASCHAL SURGICAL INSTRUMENTS, INC
Model
1
Catalog number
7-TCLCRW/TL
Device description
18cm Universal Needle Holder Thumlok® Carbide Round Handle WIDE JAWS Curved Tips
Published
2023-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B6597TCLCRWTL0PrimaryHIBCC0

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
098488463
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B659DW6R0Laschal Surgical1D2023-11-14
B659711245C0Laschal Surgical171-12-45C2023-09-06
B6597TCLRWTL0Laschal Surgical17-TCLRW/TL2023-09-06
B659BFXP900Laschal Surgical1B-FXP/902023-09-06
B659EF1450Laschal Surgical1EF-1-452023-09-06
B659TCLRM0Laschal Surgical1TCLR/M2023-09-06
B659MA1S0Laschal Surgical1MA-1S2022-07-13
B659MA450Laschal Surgical1MA-452022-07-12
B6597TCLCRMTL0Laschal Surgical17TCLCR/M/TL2020-09-11
B65990AHFL0Laschal Surgical190AHF/L2020-09-11
B659D45SPLM0Laschal Surgical1D-45SPL/M2020-09-11
B659D75SPLM0Laschal Surgical1D-75SPL/M2020-09-11
B659FNHC60Laschal Surgical1FNH-C62020-09-11
B659FNHS60Laschal Surgical1FNH-S62020-09-11
B659FNHSM0Laschal Surgical1FNH-SM2020-09-11
B65975CHFL0Laschal Surgical175CHF/L2020-09-04
B659LWL0Laschal Surgical1LW/L2020-09-04
B659LWLST0Laschal Surgical1LW/L-ST2020-09-04
B659TCLRTL0Laschal Surgical1TCLR/TL2020-09-04
B6597TCLRTL0Laschal Surgical17-TCLR/TL2020-09-01

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Primary DI, Brand, Company table
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