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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776397050MillenniumAvalign Technologies, Inc.GEN2026-07-16
00190776398651MillenniumAvalign Technologies, Inc.GEN2026-07-16
B382SD914264010Surgical DirectSurgical Direct, Inc.GEN2026-07-13
00850083275075Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275082Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275099Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275105Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275112Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275129Intrace USAPILOTIS TECH LLCGEN2026-07-03
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00850083275358Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275440Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275471Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275495Intrace USAPILOTIS TECH LLCGEN2026-07-03
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00850083275723Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275846Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275938Intrace USAPILOTIS TECH LLCGEN2026-07-03
00850083275976Intrace USAPILOTIS TECH LLCGEN2026-07-03
00860015282088Intrace USAPILOTIS TECH LLCGEN2026-07-03
00190776421656MillenniumAvalign Technologies, Inc.GEN2026-06-23
00810055258512Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258543Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258550Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258567Surgical DesignSurgical Design, Inc.GEN2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.GEN2026-06-22