FDA.reportPublic FDA data

"Lletz TENACULUM FORCEPS 9.5"""

Primary DI
G422LZ1080
Brand
"Lletz TENACULUM FORCEPS 9.5"""
Company
BIOPSY FINE CUT INSTRUMENTS
Model
LZ108
Catalog number
LZ108
Device description
"Lletz TENACULUM FORCEPS 9.5"""
Published
2023-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTDForceps

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G422LZ1080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645680898
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G422BP0110TISCHLER OVAL 21CMBP011BP0112024-10-03
G422SP0030GRAVES VAG SPEC LG 4.5SP003SP0032024-10-03
G422BP0120TISCHLER KEVORKIAN BIOPSY PUNCHBP012BP0122023-11-28
G422BP0180"TISCHLER MORGAN BIOPSY PUNCH 10"""BP018BP0182023-10-13
G422BP0190"BABY TISCHLER BIOPSY PUNCH 10"""BP019BP0192023-10-13
G422BP1090"ROTO TISCHLER BIOPSY PUNCH 10"""BP109BP1092023-10-13
G422BP0181TISCHLER MORGAN BIOPSY PUNCH 10"BP018BP0182023-10-13
G422BP0191BABY TISCHLER BIOPSY PUNCH 10"BP019BP0192023-10-13
G422BP1091ROTO TISCHLER BIOPSY PUNCH 10"BP109BP1092023-10-13
G422DL0030MINI DILATOR SET 1.0,1.5,2.0,2.5 &3.0MMDL003DL0032023-10-13
G422DL1010DILATOR CERVICAL SET OF 6DL101DL1012023-10-13
G422DL3000HANK DILATOR DOUBLE ENDED 7/8 FRDL300DL3002023-10-13
G422DL3010HANK DILATOR SET OF 6 (Z304)DL301DL3012023-10-13
G422FC0060INSTRUMENT F. REMOVAL OF I.U.D FC006FC0062023-10-13
G422SP1040PEDERSON SPECULUM MEDIUMSP104SP1042023-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD915758300Surgical DirectSurgical Direct, Inc.HTD2026-10-20
00190776435356MillenniumAvalign Technologies, Inc.HTD2026-10-19
00190776435158MillenniumAvalign Technologies, Inc.HTD2026-10-16
00192896123878Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123885Allis Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123892Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123908Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00192896123915Ceramitec Debakey ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-14
00190776434717MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434748MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434755MillenniumAvalign Technologies, Inc.HTD2026-10-12
00190776434243MillenniumAvalign Technologies, Inc.HTD2026-10-09
00190776436490MilleniumAvalign Technologies, Inc.HTD2026-10-08
B382SD9071922050Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD918660100Surgical DirectSurgical Direct, Inc.HTD2026-10-08
B382SD9013551000Surgical DirectSurgical Direct, Inc.HTD2026-10-07
B382SD9013551010Surgical DirectSurgical Direct, Inc.HTD2026-10-07
G1415140730Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G1415141510Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141514271180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
G141549012180Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-10-07
00192896123793Adson Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123809Micro Skinner ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123823Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123830Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
00192896123847Thumb Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-10-06
G141510443190Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368200Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G141511368300Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30
G14151423610Carnegie Surgical LLCCarnegie Surgical LLCHTD2026-09-30