FDA.reportPublic FDA data

TECOFLEX

Primary DI
00821925003880
Brand
TECOFLEX
Company
Gyrus ACMI, LLC
Model
5558526
Device description
8.5FR (2.81mm) X 26 cm LUBRI-FLEX OPEN TIP URETERAL STENT
Published
2015-10-24
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
FADStent, Ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FADStent, UreteralGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K905289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K905289000SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENTMedical Engineering Corp.1991-03-13FAD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925003880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925003880008219250038808219250038800821925003880

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric ureteral stentA sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18885247266xxx@xxx.xxx

Regulatory Flags#

DUNS number
007198742
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936534343020Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759149Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759156Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759163Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759170Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759231Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759248Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759255Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759262Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759323Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759330Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759347Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759354Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759415Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759422Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759439Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759446Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759682Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759699Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759705Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759712Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759774Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759781Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759798Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759804Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759866Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759873Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759880Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759897Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22
06942804759958Disposable Ureteral StentsZhejiang Chuangxiang Medical Technology Co., LTD.FAD2026-09-22