FDA.reportPublic FDA data

TRUFILL

Primary DI
20886704029363
Brand
TRUFILL
Company
CODMAN & SHURTLEFF, INC.
Model
633-360
Catalog number
633360
Device description
TRUFILL Pushable Coils 5 Vascular Occlusion Devices Compatibality (Microcatheter) 0.21 Inch ID (.5 mm) Length in Introducer 60 mm 7 mm
Published
2015-09-20
Public version status
Update
Distribution status
Not 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
HCGDEVICE, NEUROVASCULAR EMBOLIZATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCGDevice, Neurovascular EmbolizationNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123560000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123560000VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEMCodman & Shurtleff, Inc.2013-01-25HCG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886704029363PackageGS15Not in Commercial Distribution
10886704029366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088670402936320886704029363
1088670402936610886704029366

GMDN Terms#

Term, Definition table
TermDefinition
Neurovascular embolization coilA non-bioabsorbable, implantable device intended to induce a neurovascular thrombosis to treat an intracranial aneurysm and/or neurovascular arteriovenous malformation (AVM); it may also be intended to treat non-neurovascular malformations. It is in the form of a metal [e.g., platinum alloy] or metal/synthetic polymer wire which coils upon deployment within the aneurysm/vasculature; it is typically pre-attached to a nonimplantable delivery wire. Disposable devices associated with implantation (e.g., delivery wire, catheter) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away From Sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
607846297
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
20886704043826CODMANAP-09150AP091502014-09-20
20886704072888CODMANAP-04009AP040092014-09-20
20886704036675DURAFORM80-14728014722015-09-20
20886704036699DURAFORM80-14748014742015-09-20
20886704036712DURAFORM80-14768014762015-09-20
20886704036736DURAFORM80-14788014782015-09-20
20886704079429DURAFORM80-1472US801472US2016-03-22
20886704079443DURAFORM80-1474US801474US2016-03-22
20886704079467DURAFORM80-1476US801476US2016-03-22
20886704079481DURAFORM80-1478US801478US2016-03-22
20886704029172TRUFILL633-0006330002015-09-20
20886704029189TRUFILL633-0106330102015-09-20
20886704029219TRUFILL633-1206331202015-09-20
20886704029226TRUFILL633-1406331402015-09-20
20886704029233TRUFILL633-1606331602015-09-20
20886704029288TRUFILL633-3206333202015-09-20
20886704029301TRUFILL633-3306333302015-09-20
20886704029325TRUFILL633-3406333402015-09-20
20886704029349TRUFILL633-3506333502015-09-20
20886704029387TRUFILL633-3706333702015-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000495626Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495633Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495657Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000495664Axium™ Prime Detachable Coil SystemMicro Therapeutics, Inc.HCG2023-08-07
00763000488000Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488017Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488024Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488031Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488147Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488154Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488178Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488192Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488208Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488215Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488222Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488239Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488246Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488253Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488260Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488277Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488284Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488291Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488369Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488420Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488437Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488482Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488642Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488659Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488666Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28
00763000488697Axium™ Detachable Coil SystemMicro Therapeutics, Inc.HCG2022-10-28