FDA.reportPublic FDA data

WECK

Primary DI
24026704725568
Brand
WECK
Company
TELEFLEX INCORPORATED
Model
IPN920937
Catalog number
533737
Device description
HP TI SMALL 25 Clips/Cart
Published
2024-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZPClip, implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132658000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132658000HEMOCLIP TRADITIONAL LIGATING CLIPS, HEMOCLIP PLUS LIGATING CLIPS, HORIZON LIGTING CLIPSTeleflex Medical2013-11-27FZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704725568PackageGS112In Commercial Distribution
34026704725565PackageGS112In Commercial Distribution
24026704696165PreviousGS10
14026704725561PrimaryGS10
54026704725569Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2402670472556824026704725568
3402670472556534026704725565
2402670469616524026704696165
1402670472556114026704725561
5402670472556954026704725569

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Height2.69Millimeter
Length3.46Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
08904255203877MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203938MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203945MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255203952MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225503MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225510MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225527MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225534MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225541MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
08904255225558MirusTM Ligating ClipMERIL ENDO SURGERY PRIVATE LIMITEDFZP2026-04-18
14026704725301WECKTELEFLEX INCORPORATEDFZP2025-07-03
14026704613868WECKTELEFLEX INCORPORATEDFZP2025-05-13
14026704613875WECKTELEFLEX INCORPORATEDFZP2025-05-13
14026704613844WECKTELEFLEX INCORPORATEDFZP2025-04-28
14026704613851WECKTELEFLEX INCORPORATEDFZP2025-04-24
14026704725264WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725271WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725288WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725295WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725318WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725325WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725332WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725349WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725356WECKTELEFLEX INCORPORATEDFZP2024-03-13
14026704725363WECKTELEFLEX INCORPORATEDFZP2024-03-13
10193489144765MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144789MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144796MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144819MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20
10193489144826MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20