FDA.report

Laschal Surgical

Primary DI
B6597TCLCRM0
Brand
Laschal Surgical
Company
LASCHAL SURGICAL INSTRUMENTS, INC
Model
1
Catalog number
7-TCLCR/M
Device description
17.75Cm Needle Holder Micro Tip- Curved
Published
2020-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B6597TCLCRM0PrimaryHIBCC0

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
098488463
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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
B6597TCLCRMM0Laschal Surgical17TCLCR/MM2020-09-11
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
B659HAF7570Laschal Surgical1HAF/75-72020-09-11
B659HAF900Laschal Surgical1HAF/902020-09-11
B659LA1C0Laschal Surgical1LA-1C2020-09-11

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