FDA.reportPublic FDA data

STEALTH® CLAMP INSERTS

Primary DI
10607915113015
Brand
STEALTH® CLAMP INSERTS
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
A0A04
Device description
Clamp Inserts
Published
2016-09-24
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
DXCClamp, Vascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915113015PackageGS110In Commercial Distribution
00607915113018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791511301510607915113015
00607915113018006079151130186079151130180607915113018

GMDN Terms#

Term, Definition table
TermDefinition
Clamp jaw cover, sterileA sterile device used in pairs that are placed/fitted onto the distal working end (the jaws) of surgical instruments (e.g., vascular clamps, haemostats and forceps) to provide improved atraumatic grip and even pressure distribution when clamping an artery or a vein. It is typically a long device designed as a cylindrical tube and made of radiopaque silicone materials; it is available in various sizes. It may also be known as jaw covers. This is a single-use device.

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607915146467Voyant Electrosurgical GeneratorEA0302026-01-16
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915140700Alexis® Orthopaedic ProtectorHR1002024-07-11
00607915114688Threaded Cannula and SealC05682016-09-24
10607915140325Alexis® O Wound Protector-RetractorC84062022-05-27
10607915145528Inzii Ripstop Redeployable Retrieval SystemCD0052024-03-19
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
10607915140790Voyant Maryland Fusion Device with Single-Step ActivationEB2122022-12-13
00607915140809Voyant Maryland Fusion Device with Single-Step ActivationEB2132022-12-13
10607915140813Voyant Maryland Fusion Device with Single-Step ActivationEB2142022-12-13
10607915145313GelPOINT V-Path C2B112023-03-17
10607915145320GelPOINT V-Path C2B122023-03-17
10607915145337GelPOINT V-Path C2B152023-03-17
10607915145344GelPOINT V-Path C2C112023-03-17
10607915145351GelPOINT V-Path C2C122023-03-17
10607915145368GelPOINT V-Path C2C152023-03-17
10607915146693GelPOINT V-Path C2B172023-03-17
00607915145613GelPOINT V-Path C2A172023-02-17
10607915141797Alexis® Contained Extraction SystemGTB142022-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20197344138897NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
00192896122697Cooley Vascular ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122710Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122727Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00884450846032Safeguard Radial™Merit Medical Systems, Inc.DXC2026-02-20
00840479401027enableCV IntraClude™ Intra-Aortic Occlusion DeviceENABLECV INC.DXC2026-02-06
18022057015881DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015891DeTACH Aortic Cross Clamp Head- MediumCORCYM SRLDXC2026-02-03
18022057015904DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
08022057015914DeTACH Aortic Cross Clamp Delivery SystemCORCYM SRLDXC2026-02-03
08022057015921DeTACH Aortic Cross Clamp Quick Release DeviceCORCYM SRLDXC2026-02-03
08022057015945DeTACH Aortic Cross Clamp Delivery DeviceCORCYM SRLDXC2026-02-03
00810123209507Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209514Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209521Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209538Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209545Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209552Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209583Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209590Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209606Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209613Adler Instrument CompanyAdler, Inc.DXC2025-08-19
54026704930840PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930857PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930864PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930871PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930888PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930895PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
00192896121638Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17
00192896121645Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17