FDA.reportPublic FDA data

NA

Primary DI
30381780125826
Brand
NA
Company
Integra Lifesciences Corporation
Model
DFUSTAPLERKIT
Catalog number
DFUSTAPLERKIT
Device description
Box of 3 Disposable Skin Staplers
Published
2016-05-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDTStaple, Removable (Skin)
QQSStapler, skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDTStaple, Removable (Skin)General, Plastic Surgery1
QQSStapler, SkinGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30381780125826PrimaryGS10
00381780125825Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038178012582630381780125826
00381780125825003817801258253817801258250381780125825

GMDN Terms#

Term, Definition table
TermDefinition
Skin stapler/staple, non-bioabsorbableA sterile hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to approximate free edges of skin from an incision or wound. This stapler is a manually-powered device designed to mechanically deliver the staples; the staples are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)654-2873custsvcnj@integralife.com

Regulatory Flags#

DUNS number
083171244
Device count
3
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10381780272618Omni-Tract®11908119082018-02-23
20705031004334BioPatch™31502016-06-20
20705031004341BioPatch™31512016-06-20
20705031004358BioPatch™31522016-06-20
10381780541387Durepair®62105621052026-03-11
10381780541400Durepair®62110621102026-03-11
10381780541417Durepair®62111621112026-03-11
10381780541370Durepair®62100621002026-03-11
10381780541394Durepair®62106621062026-03-11
10381780541424Durepair®62158621582026-03-11
10381780537434Hermetic™ PlusINS8301INS83012024-06-28
10381780253549MAYFIELD®A1114A11142016-07-26
10381780253556MAYFIELD®A1114AA1114A2016-07-26
10381780268666Omni-Tract®3121R3121R2018-02-23
10381780269953Omni-Tract®3810R3810R2018-02-23
10381780270072Omni-Tract®3858R3858R2018-02-23
10381780270393Omni-Tract®392239222018-02-23
10381780374121AccuDrain®SP02202017-05-08
10381780542254MAYFIELD®A4000PA4000P2026-02-05
10381780542261MAYFIELD®A4000SRLA4000SRL2026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946480584057Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-05-13
06946480584026Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584040Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584118Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584125Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584132Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584149Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
06946480584156Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2026-03-13
00661392055148LSL HEALTHCARELSL Industries, LLCGDT2025-10-30
06946480584064Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2025-09-04
06946480584163Disposable Skin Staplers Sinolinks Medical Innovation Co., Ltd.QQS2025-09-04
00867469000244SubQ It! Bioabsorbable Skin Closure SystemOPUS KSD, INC.QQS2025-07-31
10867469000241SubQ It! Bioabsorbable Skin Closure SystemOPUS KSD, INC.QQS2025-07-31
06974600043207KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043214KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043221KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043238KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043245KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043252KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043269KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043276KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043283KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043290KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043306KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043313KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043320KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
06974600043337KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043204KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043211KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043228KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28