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
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16
14026704302366RUSCHIPN0505271807053002016-09-16
14026704302977RUSCHIPN0505911834052002016-09-16

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