FDA.reportPublic FDA data

SafeSheath CSG

Primary DI
10884450162009
Brand
SafeSheath CSG
Company
Merit Medical
Model
00884450162002
Catalog number
FCL-070-01
Published
2017-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120158000CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITSThomas Medical Products, Inc.2012-08-14DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884450162009PackageGS15In Commercial Distribution
00884450162002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1088445016200910884450162009
00884450162002008844501620028844501620020884450162002

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065673912
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
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
10884450452001Hydrophilic Prelude SNAP™CPLSH-1009.52026-09-12
10884450313654Prelude Prestige™10884450313654PLPS-25162020-07-16
10884450313739Prelude Prestige™10884450313739PLPS-10082021-04-09
10884450313760Prelude Prestige™10884450313760PLPS-25102020-06-02
10884450313791Prelude Prestige™10884450313791PLPS-25082020-06-02
10884450313807Prelude Prestige™10884450313807PLPS-10102021-04-09
10884450313821Prelude Prestige™10884450313821PLPS-25072020-07-16
10884450313838Prelude Prestige™10884450313838PLPS-10112021-04-09
10884450313852Prelude Prestige™10884450313852PLPS-10122021-04-09
10884450313869Prelude Prestige™10884450313869PLPS-25052020-07-16
10884450495565Hydrophilic Prelude SNAP™10884450495565PLSH-1009.5/A2021-11-22
00884450161944SafeSheath CSG00884450161944CSG-90-092017-03-14
00884450161951SafeSheath CSG00884450161951FCL-069-002017-02-20
00884450161975SafeSheath CSG00884450161975FCL-069-022018-01-15
00884450161982SafeSheath CSG00884450161982FCL-069-032017-05-24
00884450161999SafeSheath CSG00884450161999FCL-070-002017-05-08
00884450162002SafeSheath CSG00884450162002FCL-070-012017-10-16
00884450162033SafeSheath CSG00884450162033FCL-083-002017-02-15
00884450162040SafeSheath CSG00884450162040FCL-083-012017-02-15
00884450162057SafeSheath CSG00884450162057FCL-083-022017-02-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450839355Prelude Roadster™Merit Medical Systems, Inc.DYB2026-11-04
06954615625766Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626572Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626589Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626596Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
06954615626602Giranel Guiding Sheath SetKossel Medtech (Suzhou) Co., Ltd.DYB2026-11-04
00884450838228Prelude Roadster™Merit Medical Systems, Inc.DYB2026-11-03
00884450839362Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-30
00884450838129Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-29
00198715836998EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATINGFREUDENBERG MEDICAL, LLCDYB2026-01-29
00389701009261PINNACLETERUMO MEDICAL CORPORATIONDYB2018-03-21
00382903840120BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840083BD Introsyte-N Autoguard, BD InstaflashBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840106BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00382903840113BD Introsyte AutoguardBECTON, DICKINSON AND COMPANYDYB2016-10-20
00389701006161DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006178DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006185DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006192DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006208DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006215DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006222DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006239DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006246DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006253DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006260DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006277DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006796DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006802DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24
00389701006970DESTINATIONTERUMO MEDICAL CORPORATIONDYB2016-09-24