FDA.reportPublic FDA data

GEL-BEAD

Primary DI
10841156106621
Brand
GEL-BEAD
Company
TELEFLEX INCORPORATED
Model
IPN001483
Catalog number
3822
Device description
Gel-Bead
Published
2020-04-23
Public version status
Update
Distribution status
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
KRDDevice, Vascular, for Promoting Embolization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRDDevice, Vascular, For Promoting EmbolizationCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20841156106628PackageGS15In Commercial Distribution
10841156106621PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084115610662820841156106628
1084115610662110841156106621

GMDN Terms#

Term, Definition table
TermDefinition
Non-neurovascular embolization plug, animal-derivedA bioabsorbable preformed device made from animal-derived (e.g., porcine) materials intended to be implanted in a non-neurovascular blood vessel, permanently or long-term, to occlude blood flow typically for treatment of an aneurysm, tumour (e.g., nephroma, hepatoma, uterine fibroids), and/or arteriovenous malformation (AVM). It is typically in the form of a gelatin foam pledget and may be supplied with dedicated instruments for implantation. This device is not intended to be used in intracranial arteries or for other neurovascular applications.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902226188ARROWIPNB00349SI-111422026-09-28
10801902226195ARROWIPNB00348SI-112422026-09-28
10801902228205ARROWIPNB00283ASK-45703-NCC32026-09-25
10801902228212ARROWIPNB00282ASK-45802-NCC2026-09-25
10801902228700ARROWCDC-09903-1ACDC-09903-1A2026-09-22
10801902228717ARROWCDA-42703-XPCN1ACDA-42703-XPCN1A2026-09-22
04026704916955RUSCHIPN9007315640002026-08-03
10841156111519TELEFLEXIPN93068158822025-06-12
10841156111540TELEFLEXIPN93068258842025-06-12
10841156111595TELEFLEXIPN93068458882025-06-12
10841156111755TELEFLEXIPN93068358862025-06-12
14026704302182RUSCHIPN0505091807051202016-09-16
14026704302205RUSCHIPN0505111807051402016-09-16
14026704302229RUSCHIPN0505131807051602016-09-16
14026704302243RUSCHIPN0505151807051802016-09-16
14026704302267RUSCHIPN0505171807052002016-09-16
14026704302281RUSCHIPN0505191807052202016-09-16
14026704302304RUSCHIPN0505211807052402016-09-16
14026704302328RUSCHIPN0505231807052602016-09-16
14026704302342RUSCHIPN0505251807052802016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810169723586swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723593swiftMATCH Coil, Extra SoftPENUMBRA, INC.KRD2026-10-01
00810169723609swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723616swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723623swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723630swiftMATCH Coil, SoftPENUMBRA, INC.KRD2026-10-01
00810169723647swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723654swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723661swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723678swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723685swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723692swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169723708swiftMATCH Coil, StandardPENUMBRA, INC.KRD2026-10-01
00810169724217Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724224Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724231Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724248Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724255Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724262Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724279Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
00810169724286Ruby XL Coil SystemPENUMBRA, INC.KRD2026-10-01
10886704076957DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076971DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704076988DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077022DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077039DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077046DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077077DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077176DELTAFILLCerenovus, Inc.KRD2016-11-16
10886704077183DELTAFILLCerenovus, Inc.KRD2016-11-16