FDA.reportPublic FDA data

TROCARTROCAR

Primary DI
50884908005368
Brand
TROCARTROCAR
Company
Medical Components, Inc.
Model
BTH
Device description
HEMO-CATH® BLUNT TROCAR W/SLEEVE
Published
2016-10-21
Public version status
Update
Distribution status
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
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50884908005368PackageGS15In Commercial Distribution
00884908005363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5088490800536850884908005368
00884908005363008849080053638849080053630884908005363

GMDN Terms#

Term, Definition table
TermDefinition
Subcutaneous tunneller, single-useA sterile, 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. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(215)256-4201clinical@medcompnet.com

Regulatory Flags#

DUNS number
038000253
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50884908183912SLX Hemo-Cath®MC061405MC0614052026-03-21
50884908183943SLX Hemo-Cath®MC061404MC0614042026-03-21
50884908187620SLX Hemo-Cath®MC061424MBMC061424MB2026-03-21
50884908187637SLX HEMO-CATH®MC061425MBMC061425MB2026-03-21
30884908188456MICRO-STICK SETDMRAH190411DMRAH1904112026-02-19
30884908188463MICRO-STICK SETDMRAH190421DMRAH1904212026-02-19
50884908188474MICRO-STICK SETDMRAH190511DMRAH1905112026-02-19
50884908188481MICRO-STICK SETDMRAH190521DMRAH1905212026-02-19
50884908135782PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28036301MD280363012026-02-17
50884908143855PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037201MD280372012026-02-17
50884908143862PRO-LINE® CT PRESSURE INJECTABLE CVC (ISOPLAST)MD28037101MD280371012026-02-17
50884908143879PRO-PICC® CT PRESSURE INJECTABLE CVC (ISOPLAST)MR28036304MR280363042026-02-17
50884908152703PRO-PICC® CTMD17035201MD170352012026-02-17
50884908154714PRO-PICC® CTMD17036201MD170362012026-02-17
50884908154721PRO-PICC® CTMD17036301MD170363012026-02-17
50884908160234PRO-PICC® CTMD17035101MD170351012026-02-17
50884908160258PRO-PICC® CTMD17034101MD170341012026-02-17
50884908174361PRO-PICC® CTMD17035105MD170351052026-02-17
50884908184094VASCU-PICC® AND MIDLINE CATHETERSMD17013101MD170131012026-02-13
50884908184100VASCU-PICC® AND MIDLINE CATHETERSMD17013105MD170131052026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867500914Arthrex®ARTHREX, INC.DRC2026-03-13
04262494463594N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463631N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463785N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463792N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463808N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463815N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463822N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463839N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463846N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494461064N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461224N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461019N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461026N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461033N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461040N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461057N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461071N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461088N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461095N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461101N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461118N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461125N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461132N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461149N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461156N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461163N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461170N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461187N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461194N/ADoppkon GmbH & Co. KGDRC2025-08-04