FDA.reportPublic FDA data

WECK

Primary DI
04026704599882
Brand
WECK
Company
TELEFLEX INCORPORATED
Model
IPN006540
Catalog number
394246
Device description
DISPOSABLE BICEPS FORCEPS CORD UNIVERSAL FIT 10/BX
Published
2016-09-16
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
HAMAPPARATUS, ELECTROSURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAMApparatus, ElectrosurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K823755000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K823755000BICEPS ELECTROCAUTERY SYSTEMSquibb Diagnostics1983-01-26HAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704599886PackageGS110Not in Commercial Distribution
44026704599880PackageGS113Not in Commercial Distribution
04026704599882PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670459988624026704599886
4402670459988044026704599880
04026704599882040267045998824026704599882

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30801902124921ARROWIPN037387ASK-04100-AMC-S12026-10-13
14026704937001WECK5442405442402026-03-30
10841156108441ONCONTROLIPN9190129402-VC-0062022-01-21
10841156108458ONCONTROLIPN9190139403-VC-0062022-01-21
10841156108465ONCONTROLIPN9190149407-VC-0062022-01-21
10841156108472ONCONTROLIPN9190169411-VC-0062021-10-29
10841156108489ONCONTROLIPN9190179425-VC-0062022-01-20
10841156108496ONCONTROLIPN9190189451-VC-0062021-10-29
10841156108502ONCONTROLIPN9190199458-VC-0062021-10-29
10841156108564ONCONTROLIPN9190259463-VC-0062021-10-29
10841156108601ONCONTROLIPN9190299465-VC-0062021-10-29
10841156108632ONCONTROLIPN9190329468-VC-0062022-01-20
10841156108649ONCONTROLIPN9190339471-VC-0062022-01-21
10841156108656ONCONTROLIPN9190349472-VC-0062021-10-29
10841156108663ONCONTROLIPN9190359490-VC-0062022-01-20
10841156108670ONCONTROLIPN9190159408-VC-0062021-10-29
10801902228045ARROWAK-05503AK-055032026-10-09
10801902228052ARROWSJ-05501SJ-055012026-10-09
10801902228069ARROWAB-05060-PKAB-05060-PK2026-10-09
10801902228076ARROWMP-17019-TKLMP-17019-TKL2026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841019117552KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00841019117569KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00841019117576KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117559KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117566KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
10841019117573KirwanKIRWAN SURGICAL PRODUCTS LLCHAM2025-04-07
00653405002102CONMEDConmed CorporationHAM2023-11-30
20653405002106CONMEDConmed CorporationHAM2023-11-30
20653405036019ABCConmed CorporationHAM2023-10-11
14026704662118PILLINGTELEFLEX INCORPORATEDHAM2019-06-03
34026704662112PILLINGTELEFLEX INCORPORATEDHAM2019-06-03
19555240400854ITL Essential Laparoscopic Quiver ExtendableITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240401141ITL Essential Standard QuiverITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240400946ITL Essential Laparoscopic Quiver ExtendableITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
19555240400748ITL Essential Standard QuiverITL ASIA PACIFIC SDN. BHD.HAM2019-05-25
14026704662125WECKTELEFLEX INCORPORATEDHAM2019-05-08
24026704662122WECKTELEFLEX INCORPORATEDHAM2019-05-08
20888937014413LEEP Disposable Universal ElectrodesCoopersurgical, Inc.HAM2016-10-05
24026704599879WECKTELEFLEX INCORPORATEDHAM2016-09-30
04026704599875WeckTELEFLEX INCORPORATEDHAM2016-09-30
10653405002475ABCConmed CorporationHAM2016-09-24
10653405002604ABCConmed CorporationHAM2016-09-24
30653405036016ABCConmed CorporationHAM2016-09-24
30653405002103CONMEDConmed CorporationHAM2016-09-24
20653405002472ABCConmed CorporationHAM2016-09-24
20653405002601ABCConmed CorporationHAM2016-09-24
40653405036013ABCConmed CorporationHAM2016-09-24
B3964500140ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500160ESIFTT MEDICAL, INC.HAM2016-09-20
B3964500180ESIFTT MEDICAL, INC.HAM2016-09-20