FDA.reportPublic FDA data

Epix® Universal Clip Applier

Primary DI
10607915125315
Brand
Epix® Universal Clip Applier
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
CA500
Device description
Disposable Laparoscopic Clip Applier with 20 Clips.
Published
2015-07-13
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915125315PackageGS13In Commercial Distribution
00607915125318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791512531510607915125315
00607915125318006079151253186079151253180607915125318

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10607915145313GelPOINT V-PathC2B112023-03-17
10607915145320GelPOINT V-PathC2B122023-03-17
10607915145337GelPOINT V-PathC2B152023-03-17
10607915145344GelPOINT V-PathC2C112023-03-17
10607915145368GelPOINT V-PathC2C152023-03-17
10607915146693GelPOINT V-PathC2B172023-03-17
00607915110123Epix Laparoscopic ScissorsCB0302016-09-24
00607915110130Epix Laparoscopic ScissorsCB0402016-09-24
00607915142087Alexis® Lighted Wound Protector-RetractorCL4022026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorCL3022026-04-22
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceC2R122026-04-22
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
00607915110147Epix Laparoscopic GrasperC41302016-08-30
00607915110154Epix Laparoscopic GrasperC41402016-08-30
00607915116866Direct Drive Reposable GraspersC41202016-08-30
00607915116873Direct Drive Reposable GraspersC41212016-08-30
00607915126773Inzii Retrieval SystemCD0042016-09-24
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915126964Epix ® Laparoscopic Dissector CY0102016-09-24

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