FDA.reportPublic FDA data

Sklar®

Primary DI
30649111386569
Brand
Sklar®
Company
SKLAR CORPORATION
Model
21-825
Device description
ADSON DURA HOOK BLUNT 8" BX/12
Published
2018-12-14
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
true

Product Codes#

Code, Name table
CodeName
GDGHOOK, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30649111386569PrimaryGS10
00649111386568Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3064911138656930649111386569
00649111386568006491113865686491113865680649111386568

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

Regulatory Flags#

DUNS number
006966006
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10649111501326Sklar Instruments31-40742026-03-12
10649111294235Sklar®67-10202016-10-07
40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
40649111234102Sklar Instruments96-11462025-11-11
50649111095045Sklar Instruments94-02902025-06-15
50649111232921Sklar Instruments941-01922025-06-15
50649111344174Sklar Instruments941-09182025-06-15
50649111400115Sklar Instruments941-12592025-06-15
50649111400122Sklar Instruments941-12602025-06-15
50649111400139Sklar Instruments941-12612025-06-15
50649111447752Sklar Instruments941-15562025-06-15
50649111447912Sklar Instruments941-16132025-06-15
50649111469907Sklar Instruments941-13202025-06-15
50649111050402Sklar Instruments96-25162025-05-29
50649111050594Sklar Instruments96-25172025-05-29
50649111081109Sklar Instruments96-26802025-05-29
50649111081499Sklar Instruments96-26822025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776417901MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418335MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418366MillenniumAvalign Technologies, Inc.GDG2026-03-23
04052536215522tezoUlrich GmbH & Co. KGGDG2026-03-16
00810158219328PRINCETONPrinceton Medical Group, Inc.GDG2026-03-12
00190776417826MillenniumAvalign Technologies, Inc.GDG2026-03-11
00190776417673MillenniumAvalign Technologies, Inc.GDG2026-03-04
00190776417512MillenniumAvalign Technologies, Inc.GDG2026-02-27
00190776416775MillenniumAvalign Technologies, Inc.GDG2026-02-20
00190776415761MillenniumAvalign Technologies, Inc.GDG2026-02-04
00190776415204MillenniumAvalign Technologies, Inc.GDG2026-01-27
00198506087431ELMED INCORPORATEDELMED INCORPORATEDGDG2026-01-07
03662663277082Timberline Lateral Fusion SystemHighridge Medical, LLCGDG2025-12-18
03662663277099Timberline Lateral Fusion SystemHighridge Medical, LLCGDG2025-12-18
03662663192798Breckenridge ACDF SystemHighridge Medical, LLCGDG2025-12-15
03662663192804Breckenridge ACDF SystemHighridge Medical, LLCGDG2025-12-15
00190776415129MillenniumAvalign Technologies, Inc.GDG2025-12-03
03662663131230Disc Preparation InstrumentsHighridge Medical, LLCGDG2025-12-03
03662663131247Disc Preparation InstrumentsHighridge Medical, LLCGDG2025-12-03
09348811019653INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-12-02
09348811108647INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-28
09348811155368INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-28
00810207782605Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782612Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782629Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782636Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782643Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782650Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782667Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782674Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24