FDA.reportPublic FDA data

GEL-BLOCK

Primary DI
20841156105652
Brand
GEL-BLOCK
Company
TELEFLEX INCORPORATED
Model
IPN001468
Catalog number
3640
Device description
Gel-Block
Published
2022-12-29
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
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
20841156105652PackageGS15In Commercial Distribution
10841156105655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2084115610565220841156105652
1084115610565510841156105655

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000936594Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936600Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936617Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936624Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936631Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936648Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936655Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936662Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936679Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936686Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936693Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936709Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936716Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936723Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936730Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936747Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936754Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936761Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936778Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936785Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936792Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936808Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936815Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936822Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936839Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936846Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936853Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936860Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936877Concerto Versa™MEDTRONIC, INC.KRD2026-02-27
00763000936884Concerto Versa™MEDTRONIC, INC.KRD2026-02-27