FDA.reportPublic FDA data

ClosureFast

Primary DI
10884521140387
Brand
ClosureFast
Company
Covidien LP
Model
MPK-5F
Device description
Micro Puncture Kit
Published
2017-05-24
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
OFLPercutaneous sheath introducer kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFLPercutaneous Sheath Introducer KitCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521140384PackageGS1100In Commercial Distribution
10884521140387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452114038420884521140384
1088452114038710884521140387

GMDN Terms#

Term, Definition table
TermDefinition
General surgical procedure kit, non-medicated, reusableA typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, but that does not contain pharmaceuticals, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge5French

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521703827Tri-Staple 2.0SIGCIR21MTORVIL2026-08-09
10884521703834Tri-Staple 2.0SIGCIR21XTORVIL2026-08-09
10884521703841Tri-Staple 2.0SIGCIR25MTORVIL2026-08-09
10884521703858Tri-Staple 2.0SIGCIR25XTORVIL2026-08-09
10884521782648ValleylabE105202021-07-12
10884521703797Tri-Staple 2.0SIGCIR21XT2026-07-31
10884521703810Tri-Staple 2.0SIGCIR25XT2026-07-31
10884521102163Vascufil88864788-05V2015-08-31
10884522006545Shiley10DCFS2015-08-28
10884522030021Shiley5.0 PDL2015-09-15
10884522030083Shiley6.0 PDL2015-09-15
20884522029022Shiley8DCT2015-08-31
20884522029114Shiley4.5PDC2015-10-20
20884522031957Shiley10LPC-S2015-08-28
20884522031964Shiley4LPC-S2015-08-28
20884522031988Shiley8LPC-S2017-05-25
30884522026653Shiley3.0 NEO2015-09-15
30884522026684Shiley4.5 NEO2015-10-12
10884521833869EndoflipEF-301-RFB2024-04-12
10884521855359GI GeniusGGM300-US-RFB2026-07-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810050855808Typenex Introducer SetTYPENEX MEDICAL LLCOFL2025-11-17
H965459000Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459010Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459020Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459150Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459160Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459170Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
H965459180Navilyst MedicalAngiodynamics, Inc.OFL2024-10-21
10197106004050CARDINAL HEALTHCardinal Health 200, LLCOFL2022-10-27
00810050853774Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853804Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853811Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853842Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-08-11
00810050853460Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
00810050853491Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
00810050853514Typenex Introducer SetTYPENEX MEDICAL LLCOFL2021-01-26
00810050851954Typenex Introducer SetTYPENEX MEDICAL LLCOFL2020-06-09
00812269033763Typenex Introducer SetTYPENEX MEDICAL LLCOFL2020-02-24
00812269033800Typenex Introducer SetTYPENEX MEDICAL LLCOFL2020-02-24
00812269032957Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269032971Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269032995Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033015Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033039Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033053Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033077Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033091Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033114Typenex Introducer SetTYPENEX MEDICAL LLCOFL2019-09-18
00812269033138Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18
00812269033152Typenex Introducer Set TYPENEX MEDICAL LLCOFL2019-09-18