FDA.reportPublic FDA data

Sklar®

Primary DI
30649111334263
Brand
Sklar®
Company
SKLAR CORPORATION
Model
24-1116
Device description
WACHENFELDT WOUND CLIPS 16MM
Published
2019-01-09
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

Related Records

Product Codes

CodeName
GDOApplier, surgical, clip

Product Code Classifications

CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30649111334263PrimaryGS10
00649111334262Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3064911133426330649111334263
00649111334262006491113342626491113342620649111334262

GMDN Terms

TermDefinition
Scalp wound clipA small, nonimplantable device in the form of a U-shaped clip that is fired from a dedicated scalp-clip applier (clip gun) or manually applied using dedicated scalp clip forceps, to approximate the margins of a scalp wound/incision associated with a surgical intervention on the cranium/scalp. It is made of metal or plastic materials and is typically applied in rows; it is intended to remain in place until the incision has healed. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
006966006
Device count
100
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

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

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24026704921359WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921366WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921373WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921380WECKTELEFLEX INCORPORATEDGDO2026-03-10
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24026704921410WECKTELEFLEX INCORPORATEDGDO2026-03-10
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24026704921441WECKTELEFLEX INCORPORATEDGDO2026-03-10
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24026704921670WECKTELEFLEX INCORPORATEDGDO2026-03-10
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B382SD5715300Surgical DirectSurgical Direct, Inc.GDO2026-03-09
B382SD87531140Surgical DirectSurgical Direct, Inc.GDO2026-03-09
B382SD32155560Surgical DirectSurgical Direct, Inc.GDO2026-02-26
B382SD32155520Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155530Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155540Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155550Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32152540Surgical DirectSurgical Direct, Inc.GDO2026-02-20
14026704935496WECKTELEFLEX INCORPORATEDGDO2026-02-06