FDA.reportPublic FDA data

N/A

Primary DI
00884908144673
Brand
N/A
Company
Medical Components, Inc.
Model
DMC3B
Device description
15.5F HEMO-FLOW®/15.5F TITAN TUNNELER
Published
2019-08-28
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
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908144678PackageGS15In Commercial Distribution
00884908144673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490814467850884908144678
00884908144673008849081446738849081446730884908144673

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA hand-held manual surgical instrument designed to create a subcutaneous tunnel (artificial passageway) between percutaneous entry and exit incisions for the subcutaneous placement of a device (e.g., catheter for medication administration, shunt). It is available in a variety of forms and may be: 1) a luminal sheath with a removable inner obturator, intended for co-axial device introduction, followed by sheath removal; or 2) a non-luminal device intended to either lead or pull the device through subcutaneous tissue. It is not intended for tunnelling through deep tissues and is not a dedicated pacing or defibrillation lead tunneller. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
2152564201complaints@medcompnet.com

Regulatory Flags#

DUNS number
038000253
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
00884908057409Vascu-PICC®VP1.9S50-NS2015-11-17
00884908085693Vascu-PICC®MR170126012015-10-22
00884908185386Vascu-PICC®VP1.9S50-NSVP1.9S50-NS2025-11-20
00884908034646Pro-Line® CTMR280372012015-10-22
00884908189674MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641501DMC6415012026-08-08
00884908189681MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641502DMC6415022026-08-08
00884908189698MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641503DMC6415032026-08-08
00884908189704MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641504DMC6415042026-08-08
00884908189711MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641505DMC6415052026-08-08
00884908189728MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDMC641506DMC6415062026-08-08
00884908166330T-3 Triple Lumen CTMC013505MC0135052026-07-24
00884908185157MEDCOMP HEMO-FLOW DOUBLE LUMEN CATHETERDTHD155165DTHD1551652025-11-27
00884908092752T-3 Triple Lumen CTMC0135022015-10-23
00884908092769T-3 TRIPLE LUMEN CTMC0135032016-02-23
00884908016901GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREG130NG130N2018-10-06
00884908105254GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREMR1900202017-11-28
00884908105278GALT MEDICAL GUIDEWIREGALT MEDICAL GUIDEWIREMR1900402017-12-02
00884908145090GALT GUIDEWIREGALT GUIDEWIREDMR190040DMR1900402019-09-04
00884908136630DUO-FLOW® SIDE X SIDEAS0914151AS09141512026-05-13
00884908136647DUO-FLOW® SIDE X SIDEAS0914201AS09142012026-05-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450735916Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735906Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735920Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735944Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735968Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735975Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450735999Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736033Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736057Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736071Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736118Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736132Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736149Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736187Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736224Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736262Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736309Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736361Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736385Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736439Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736446Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736491Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736507Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450736552Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739317Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739348Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
10884450739379Merit Advance®Merit Medical Systems, Inc.DRC2026-10-19
00810212933825SURGIPROSSurgipros, LLCDRC2026-07-28
00810212933832SURGIPROSSurgipros, LLCDRC2026-07-28
00810212933849SURGIPROSSurgipros, LLCDRC2026-07-28