FDA.reportPublic FDA data

WECK

Primary DI
14026704695895
Brand
WECK
Company
TELEFLEX INCORPORATED
Model
IPN915201
Catalog number
AE05ML
Device description
AUTOMATIC END0SCOPIC 5 MEDIUM LARGE
Published
2024-01-31
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

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
K230480000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230480000Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML)Teleflex Medical2023-04-28FZP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14026704695895PackageGS11In Commercial Distribution
34026704695899PackageGS13In Commercial Distribution
44026704695896PackageGS16In Commercial Distribution
24026704695892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1402670469589514026704695895
3402670469589934026704695899
4402670469589644026704695896
2402670469589224026704695892

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, synthetic polymer, non-bioabsorbableA non-metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel or a tissue bundle for permanent occlusion. It is typically made of plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and may be designed with a self-locking catch. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries, but is usually not intended for fallopian tube occlusion. Its non-metallic design makes it more compatible with radiological imaging than metallic clips. A dedicated, disposable clip applier may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Centimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
34026704921394WECKTELEFLEX INCORPORATEDFZP2026-01-13
24026704921328WECKTELEFLEX INCORPORATEDFZP2025-08-25
24026704725308WECKTELEFLEX INCORPORATEDFZP2025-07-03
44026704613869WECKTELEFLEX INCORPORATEDFZP2025-05-13
44026704613876WECKTELEFLEX INCORPORATEDFZP2025-05-13
34026704613848WECKTELEFLEX INCORPORATEDFZP2025-04-28
44026704613852WECKTELEFLEX INCORPORATEDFZP2025-04-24
44026704933608WECKTELEFLEX INCORPORATEDFZP2025-04-24
44026704933639WECKTELEFLEX INCORPORATEDFZP2025-04-24
34026704933663WECKTELEFLEX INCORPORATEDFZP2025-04-24
44026704912627WECKTELEFLEX INCORPORATEDFZP2025-04-04
44026704912634WECKTELEFLEX INCORPORATEDFZP2025-04-04
34026704922971WECKTELEFLEX INCORPORATEDFZP2025-04-04
10844735006381ZIPCLIPSYNOVIS MICRO COMPANIES ALLIANCE, INCFZP2025-03-04
44026704933301WECKTELEFLEX INCORPORATEDFZP2024-11-15
00842180152748ELMEDELMED INCORPORATEDFZP2024-06-18
24026704725261WECKTELEFLEX INCORPORATEDFZP2024-03-13
34026704725275WECKTELEFLEX INCORPORATEDFZP2024-03-13
34026704725282WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725292WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725315WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725322WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725339WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725346WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725353WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725360WECKTELEFLEX INCORPORATEDFZP2024-03-13
34026704725459WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725469WECKTELEFLEX INCORPORATEDFZP2024-03-13
24026704725476WECKTELEFLEX INCORPORATEDFZP2024-03-13
34026704725480WECKTELEFLEX INCORPORATEDFZP2024-03-13