FDA.reportPublic FDA data

Laschal Surgical

Primary DI
B659FNHS60
Brand
Laschal Surgical
Company
LASCHAL SURGICAL INSTRUMENTS, INC
Model
1
Catalog number
FNH-S6
Device description
15cm Micro Needle Holder Thumlok® Diamond Round-Handle Straight Micro Tips
Published
2020-09-11
Public version status
Update
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
B659FNHS60PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
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
DM exempt
true
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
B6597TCLCRWTL0Laschal Surgical17-TCLCRW/TL2023-09-06
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
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
00840329838669N/ABLACK & BLACK SURGICAL, INC.GEN2026-10-15
00190776435011MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435035MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776434816MillenniumAvalign Technologies, Inc.GEN2026-10-13
00190776434779MillenniumAvalign Technologies, Inc.GEN2026-10-12
04058749012842NAFehling Instruments GmbH & Co. KGGEN2026-10-12
00190776434175MillenniumAvalign Technologies, Inc.GEN2026-10-09
00198506095801ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095818ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095825ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095832ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00840314252449gSourceGSOURCE LLCGEN2026-10-09
00190776436605MilleniumAvalign Technologies, Inc.GEN2026-10-08
00190776433604MillenniumAvalign Technologies, Inc.GEN2026-10-07
00190776434380MillenniumAvalign Technologies, Inc.GEN2026-10-07
B382SD6713210Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6713290Surgical DirectSurgical Direct, Inc.GEN2026-10-07
B382SD6520450Surgical DirectSurgical Direct, Inc.GEN2026-10-06
B382SD6562120Surgical DirectSurgical Direct, Inc.GEN2026-10-06
00190776433048MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433130MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433147MillenniumAvalign Technologies, Inc.GEN2026-10-01
00190776433178MillenniumAvalign Technologies, Inc.GEN2026-10-01
B382SD8160490Surgical DirectSurgical Direct, Inc.GEN2026-09-30
00190776432829MillenniumAvalign Technologies, Inc.GEN2026-09-29
00190776432898MillenniumAvalign Technologies, Inc.GEN2026-09-29
B382SD4937851340Surgical DirectSurgical Direct, Inc.GEN2026-09-29
00190776432522MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432553MillenniumAvalign Technologies, Inc.GEN2026-09-28
00190776432560MillenniumAvalign Technologies, Inc.GEN2026-09-28