FDA.reportPublic FDA data

WECK

Primary DI
44026704696053
Brand
WECK
Company
TELEFLEX INCORPORATED
Model
IPN915064
Catalog number
523700
Device description
HEMOCLIP TI MED 25 Clips/Cart
Published
2021-01-11
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
34026704696056PackageGS110In Commercial Distribution
44026704696053PackageGS112In Commercial Distribution
24026704696059PrimaryGS10
14026704696052Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3402670469605634026704696056
4402670469605344026704696053
2402670469605924026704696059
1402670469605214026704696052

GMDN Terms#

Term, Definition table
TermDefinition
Ligation clip, metallicA sterile, 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
Height4.49Millimeter
Length5.79Millimeter

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
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
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
14026704935779WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935786WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935809WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935823WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704935847WECKTELEFLEX INCORPORATEDFZP2026-08-15
14026704725424WECKTELEFLEX INCORPORATEDFZP2026-08-01
00198506092794ELMED INCORPORATEDELMED INCORPORATEDFZP2026-07-28
04717480902064InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902101InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902149InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902170InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902217InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
04717480902293InnoClipTAIWAN SURGICAL CORPORATIONFZP2026-06-05
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
24026704695892WECKTELEFLEX INCORPORATEDFZP2024-01-31
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
10193489144840MedlineMEDLINE INDUSTRIES, INC.FZP2023-12-20