FDA.report

WECK

Primary DI
34026704736288
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
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
QQSStapler, skin

Product Code Classifications

CodeDeviceSpecialtyClass
QQSStapler, SkinGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704736288PackageGS16In Commercial Distribution
44026704736285PackageGS110In Commercial Distribution
14026704631770PreviousGS10
14026704736284PrimaryGS10
24026704736281Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670473628834026704736288
4402670473628544026704736285
1402670463177014026704631770
1402670473628414026704736284
2402670473628124026704736281

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
35
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
10867469000241SubQ It! Bioabsorbable Skin Closure SystemOPUS KSD, INC.QQS2025-07-31
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
16974600043242KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043259KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043266KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043273KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043280KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043297KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043303KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043310KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043327KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
16974600043334KONLIDASuzhou Konlida Medical Supplies Co., Ltd.QQS2025-07-28
10867469000234SubQ It! Bioabsorbable Skin Closure SystemOPUS KSD, INC.QQS2025-03-07
34026704736318WECKTELEFLEX INCORPORATEDQQS2024-07-09
34026704736295WECKTELEFLEX INCORPORATEDQQS2023-11-29
34026704736301WECKTELEFLEX INCORPORATEDQQS2023-11-29
10867469000227SubQ It! Bioabsorbable Skin Closure SystemOPUS KSD, INC.QQS2023-08-02
04717480906024SkinPlusTAIWAN SURGICAL CORPORATIONQQS2023-07-11