FDA.reportPublic FDA data

Soft/Fibra® Spring Clip

Primary DI
10607915118010
Brand
Soft/Fibra® Spring Clip
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
G-6050
Device description
Indicated for surgical clamping during cardiovascular peripheral vascular, and general surgery.
Published
2015-07-20
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
DSSClip, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSSClip, VascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915118010PackageGS115In Commercial Distribution
00607915118013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791511801010607915118010
00607915118013006079151180136079151180130607915118013

GMDN Terms#

Term, Definition table
TermDefinition
Vascular clamp, single-useA sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6Millimeter

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
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
00607915117382Inzii Retrieval SystemCD0012016-09-24
00607915123406Inzii Retrieval SystemCD0032016-09-24
00607915128760Epix® Reusable ProbeC72022016-08-19
00607915128777Epix® Reusable ProbeC72112016-08-19
00607915128784Epix® Reusable ProbeC72042016-08-19
00607915128791Epix® Reusable ProbeC72052016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704531787PILLINGTELEFLEX INCORPORATEDDSS2016-09-16
24026704515275PILLINGTELEFLEX INCORPORATEDDSS2016-09-16
04026704515271PillingTELEFLEX INCORPORATEDDSS2016-09-16
04026704531783PILLINGTELEFLEX INCORPORATEDDSS2016-09-16
00607915110574Stealth® Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-12-15
10607915110571Stealth® Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-12-15
00607915111373Soft/Fibra®APPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
00607915111533Soft/Fibra® 1/2 forceAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
00607915117887Sof/Soft Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
00607915117993Soft/Soft Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
00607915118013Soft/Fibra® Spring Clip APPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
00607915118037Soft/Fibra® Spring Clip 1/2 forceAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
00607915118051Soft/Fibra® Spring Clip 1/4 forceAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
10607915111370Soft/Fibra®APPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
10607915111530Soft/Fibra® 1/2 forceAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
10607915117884Sof/Soft Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
10607915117990Soft/Soft Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
10607915118034Soft/Fibra® Spring Clip 1/2 forceAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
10607915118058Soft/Fibra® Spring Clip 1/4 forceAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-07-20
00607915110581Stealth® Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
00607915110598Latis® Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
00607915110604Latis®APPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
00607915110611Latis® Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
00607915110628Stealth® Soft/Fibra® Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
00607915110734Soft/Soft Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
00607915113902Stealth® Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
00607915113919Stealth® Soft/Fibra®APPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
00607915113926Stealth® Soft/Fibra®APPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
00607915110567Stealth® Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19
10607915110588Stealth® Spring ClipAPPLIED MEDICAL RESOURCES CORPORATIONDSS2015-06-19