FDA.reportPublic FDA data

NA

Primary DI
ESOT000891
Brand
NA
Company
S & T AG
Model
CL-14
Catalog number
00089
Device description
CL-14 Needle Holder with lock, 14.5 cm long, flat, curved
Published
2022-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESOT000891PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+41526727407info@s-and-t.net

Regulatory Flags#

DUNS number
481542926
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
ESOT010801NACB-1.A010802026-01-20
ESOT000801NACB-1000802022-09-15
ESOT010751NAICL-1323-0.A010752023-03-01
ESOT011851NAICH-1323-0.A011852023-03-01
ESOT000711NACAF-4 L000712022-09-15
ESOT000721NACAF-4000722022-09-15
ESOT000731NACAF-5 L000732022-09-15
ESOT000741NACAF-5000742022-09-15
ESOT000751NAICL-1323-0000752022-09-15
ESOT000761NAICE-2427-0000762022-09-15
ESOT000821NAB-13-10000822022-09-15
ESOT000831NABL-13-10000832022-09-15
ESOT000841NAB-13-8000842022-09-15
ESOT000851NABL-13-8000852022-09-15
ESOT000861NAB-18-10000862022-09-15
ESOT000871NAB-18-8000872022-09-15
ESOT000881NAC-14000882022-09-15
ESOT000901NASDC-11000902022-09-15
ESOT000911NASDC-15000912022-09-15
ESOT000921NASDC-15 S000922022-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776411534MillenniumAvalign Technologies, Inc.MDM2026-08-07
00190776423575MillenniumAvalign Technologies, Inc.MDM2026-08-07
00190776424435MillenniumAvalign Technologies, Inc.MDM2026-08-07
B382SD923286060Surgical DirectSurgical Direct, Inc.MDM2026-08-07
00190776422806MillenniumAvalign Technologies, Inc.MDM2026-08-03
00198506092350ELMED INCORPORATEDELMED INCORPORATEDMDM2026-07-29
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