FDA.report

Sklar

Primary DI
10649111402173
Brand
Sklar
Company
SKLAR CORPORATION
Model
16-3705
Device description
SIMS TC UTER SCISS 9 INCHES CV SH/SH
Published
2019-06-17
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
LRWSCISSORS, GENERAL, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10649111402173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1064911140217310649111402173

GMDN Terms

TermDefinition
Gynaecological scissors, reusableA hand-held manual surgical instrument designed to cut tissues during a gynaecological surgical procedure; it is not intended for obstetric use. It is comprised of two pivoted shearing blades with finger and thumb ring-handles (i.e., not pinch-grip design) whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may have carbide inserts along the cutting edges. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
006966006
Device count
1
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
true

Other Devices From This Company

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40649111231422Sklar Instruments96-11302025-11-11
40649111233150Sklar Instruments96-11402025-11-11
40649111233501Sklar Instruments96-11422025-11-11
40649111233785Sklar Instruments96-11442025-11-11
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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

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00190776394127MillenniumAvalign Technologies, Inc.LRW2026-03-11
00190776417833MillenniumAvalign Technologies, Inc.LRW2026-03-11
00810158218987PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00810158218994PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00810158219168PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00192896122734Metzenbaum ScissorsSONTEC INSTRUMENTS, INC.LRW2026-03-10
04058749117462NAFehling Instruments GmbH & Co. KGLRW2026-03-05
04058749121995NAFehling Instruments GmbH & Co. KGLRW2026-03-05
04058749122008NAFehling Instruments GmbH & Co. KGLRW2026-03-05
00198506088605ELMED INCORPORATEDELMED INCORPORATEDLRW2026-02-23
00190776417277MillenniumAvalign Technologies, Inc.LRW2026-02-20
00190776417291MillenniumAvalign Technologies, Inc.LRW2026-02-20
00810058670540ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00810058670557ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
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00810097677043ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00840306837340Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LRW2026-02-18
00840306837357Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LRW2026-02-18
00810097676947ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
00810097676954ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
00810097676961ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
00810097676978ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
G4254009010My MedicalMy Medical Store LLCLRW2026-02-17
G425400913SCP0My MedicalMy Medical Store LLCLRW2026-02-17
00810158218918PRINCETONPrinceton Medical Group, Inc.LRW2026-02-16
04059453062468Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-02-13
09348811000873INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-13
09348811000897INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-13