FDA.reportPublic FDA data

Angio-Seal™

Primary DI
05415067002853
Brand
Angio-Seal™
Company
ST. JUDE MEDICAL CARDIOVASCULAR DIVISION
Model
VIP
Catalog number
610131
Published
2014-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MGBDEVICE, HEMOSTASIS, VASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGBDevice, Hemostasis, VascularUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15415067002850PackageGS12Not in Commercial Distribution
25415067002857PackageGS15Not in Commercial Distribution
05415067002853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541506700285015415067002850
2541506700285725415067002857
05415067002853054150670028535415067002853

GMDN Terms#

Term, Definition table
TermDefinition
Femoral artery closure plug/patch, collagenAn implantable, bioabsorbable device designed for haemostasis/closure of a femoral artery access (catheterization) site, through pressure/compression, as an alternative to manual compression or surgical techniques to reduce the time to haemostasis, it may additionally be intended for femoral vein access site closure. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.
Storage Environment Temperature00

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
040960379
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
true
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
05414734054591Angio-Seal™VIP6101302014-10-24
05415067002839Angio-Seal™Evolution™C6101342014-10-24
05415067002846Angio-Seal™Evolution™C6101352014-10-24
05415067002860Angio-Seal™STS Plus6101192014-10-24
05415067002877Angio-Seal™STS Plus6101212014-10-24
05414734202701Livewire™4019424019422023-10-31
05414734202176Livewire™4015724015722015-03-05
05414734202312Livewire™4016004016002015-03-05
05414734202329Livewire™4016034016032015-03-05
05414734202336Livewire™4016064016062015-03-05
05414734202350Livewire™4016484016482015-03-05
05414734202411Livewire™4016544016542015-03-05
05414734202596Livewire™4019184019182015-03-05
05414734202633Livewire™4019334019332015-03-05
05414734202640Livewire™4019344019342015-03-05
05414734202657Livewire™4019354019352015-03-05
05414734202763Livewire™4020224020222015-03-05
05414734202398Livewire™4016524016522015-02-06
05414734001052Pacel™4017664017662015-07-31
05414734001076Pacel™4017674017672015-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10841156111335MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111359MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111373MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156111397MANTATELEFLEX INCORPORATEDMGB2025-10-13
10841156103439D-STATTELEFLEX INCORPORATEDMGB2025-07-16
20841156103436D-STATTELEFLEX INCORPORATEDMGB2025-07-16
05391530280617Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280648Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280624Celt ACD PLUS Vascular Closure Device 5FVASORUM LIMITEDMGB2025-04-24
05391530280655Celt ACD PLUS Vascular Closure Device 6FVASORUM LIMITEDMGB2025-04-24
05391530280679Celt ACD PLUS Vascular Closure Device 7FVASORUM LIMITEDMGB2025-04-24
10841156109905MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109929MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109936MANTATELEFLEX INCORPORATEDMGB2024-09-09
10841156109950MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109902MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109926MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109933MANTATELEFLEX INCORPORATEDMGB2024-09-09
20841156109957MANTATELEFLEX INCORPORATEDMGB2024-09-09
10705032090278MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
20705032090275MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12FCordis US Corp.MGB2024-07-05
M7298001012XL0Cardiva VASCADE MVP XL VVCS 10-12FCARDIVA MEDICAL, INC.MGB2024-05-29
M7298001012XL2Cardiva VASCADE MVP XL VVCS 10-12FCARDIVA MEDICAL, INC.MGB2024-05-29
10841156109080D-STATTELEFLEX INCORPORATEDMGB2023-12-11
20841156109087D-STATTELEFLEX INCORPORATEDMGB2023-12-11
00856279007307MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007321MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007345MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23
00856279007369MANTAESSENTIAL MEDICAL, INC.MGB2023-10-23