FDA.reportPublic FDA data

Sklar®

Primary DI
10649111143342
Brand
Sklar®
Company
SKLAR CORPORATION
Model
78-3522
Device description
"ITERSON HOOK SH SMO HDL 6 3/4"""
Published
2018-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KCHHOOK, TRACHEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCHHook, TrachealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10649111143342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1064911114334210649111143342

GMDN Terms#

Term, Definition table
TermDefinition
Skin/tissue hookA hand-held manual surgical instrument designed to hook skin or tissue in order to grasp, apply traction, and lift the skin/tissue during a surgical intervention. It is typically a shaft-like instrument with small double hooks at the distal end and a handle at the proximal end. The hooks are curved in opposite directions and when the device is placed onto the skin or tissue to be grasped, it is twisted clockwise so that the hooks lock into the skin/tissue. Also known as a tissue pick, it is not unlike a hooked wound retractor. It is made of high-grade stainless steel and may be supplied with a cylindrical steel protecting sheath for storage and sterilization. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
006966006
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
10649111183386Sklar40-73122019-09-24
10649111183560Sklar40-73132019-09-24
10649111183713Sklar40-73142019-09-24
10649111183881Sklar40-73152019-09-24
10649111183997Sklar40-73162019-09-24
10649111184260Sklar40-73172019-09-24
10649111184420Sklar40-73182019-09-24
10649111187896Sklar40-73402019-09-24
10649111087431Sklar Instruments96-01922025-11-12
10649111225369Sklar Instruments96-10922025-11-12
10649111226281Sklar Instruments96-10972025-11-12
10649111226458Sklar Instruments96-10982025-11-12
10649111226762Sklar Instruments96-11002025-11-12
10649111226984Sklar Instruments96-11022025-11-12
10649111227370Sklar Instruments96-11052025-11-12
10649111228056Sklar Instruments96-11102025-11-12
10649111228919Sklar Instruments96-11152025-11-12
10649111229817Sklar Instruments96-11202025-11-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613031459MSI Precision Specialty InstrumentsMed Saver, Inc.KCH2025-08-01
04049047041801GimmiGimmi GmbHKCH2025-05-08
04049047014348GimmiGimmi GmbHKCH2025-04-24
04049047038078GimmiGimmi GmbHKCH2025-04-24
00887482058640Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.KCH2024-08-07
00840183513825BR Surgical, LLCBR Surgical, LLCKCH2024-06-10
00190776390204MillenniumAvalign Technologies, Inc.KCH2024-05-31
00190776388997MillenniumAvalign Technologies, Inc.KCH2024-05-16
G043280300BEARBear-Ent, LLCKCH2024-04-25
00888515035676BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035683BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035690BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035706BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035720BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035737BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035744BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
00888515035751BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.KCH2024-02-28
G586G93151250Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
G586G93151260Novo SurgicalNOVO SURGICAL, INC.KCH2023-12-18
00190776045661AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776045678AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776045777AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776223892AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776223939AvalignAvalign Technologies, Inc.KCH2023-09-28
00190776321413MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321437MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321468MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321505MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
00190776321512MILLENNIUMAvalign Technologies, Inc.KCH2023-09-28
G2231336220Medetz Surgical InstrumentsMedetz Surgical Instruments LLCKCH2023-08-23