FDA.reportPublic FDA data

Direct Drive® Clip Applier

Primary DI
00607915117306
Brand
Direct Drive® Clip Applier
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
CA090
Device description
Disposable Laparoscopic Clip Applier with 20 Clips
Published
2015-03-20
Public version status
Update
Distribution status
Not 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
FZPClip, Implantable
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915117303PackageGS13Not in Commercial Distribution
00607915117306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791511730310607915117303
00607915117306006079151173066079151173060607915117306

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
Length32Centimeter
Outer Diameter10Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Handle with care. Product should be stored in a clean, cool, dry area away from chemical fumes.

Contacts#

Phone, Email table
PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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

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