FDA.reportPublic FDA data

WECK

Primary DI
14026704736284
Brand
WECK
Company
TELEFLEX INCORPORATED
Model
IPN917212
Catalog number
528135
Device description
VISISTAT 35R 6/BOX
Published
2023-11-29
Public version status
New
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
QQSStapler, skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QQSStapler, SkinGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
34026704736288PackageGS16In Commercial Distribution
44026704736285PackageGS110In Commercial Distribution
14026704631770PreviousGS10
14026704736284PrimaryGS10
24026704736281Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670473628834026704736288
4402670473628544026704736285
1402670463177014026704631770
1402670473628414026704736284
2402670473628124026704736281

GMDN Terms#

Term, Definition table
TermDefinition
Skin stapler/staple, non-bioabsorbableA hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to apply the staples to approximate the free skin edges of an incision or wound. The staples (which may be clip-like) 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.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
35
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

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
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
16974600043235KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28