← Back to catalogue

Jawz Endomyocardial Biopsy Forceps

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 190065

by Argon Medical Devices, Inc.

Identity

Trade Name
JAWZ Biopsy Forceps EUDAMED
Jawz Endomyocardial Biopsy Forceps FDA UDI
Jawz Endomyocardial Biopsy Forcep FDA UDI
Generic Name
Endomyocardial biopsy forceps, single-use FDA UDI
Device Name
JAWZ Biopsy Forceps EUDAMED
Jawz Endomyocardial Biopsy Forceps 7F x 50cm Pre-Curved FDA UDI
Jawz Endomyocardial Biopsy Forceps 6F x 50cm Straight FDA UDI
Model / Reference
190065 EUDAMEDFDA UDI
190080 FDA UDI
Description
Jawz Endomyocardial Biopsy Forceps 7F x 50cm Pre-Curved FDA UDI
Jawz Endomyocardial Biopsy Forceps 6F x 50cm Straight FDA UDI

Identifiers

Catalog Number
190080 FDA UDI
190065 FDA UDI
Primary DI / UDI-DI
20886333206777 EUDAMED
00886333206810 FDA UDI
00886333206773 FDA UDI
Basic UDI-DI
B-20886333206777 EUDAMED
510(k) Number
K951447 FDA UDI
FDA Product Code
DWZ FDA UDI
EMDN Code
C01901102 MYOCARDIAL BIOPSY KITS EUDAMED
GMDN Term
Endomyocardial biopsy forceps, single-use FDA UDI

Classification

Device Class
Class III EUDAMED
Class II FDA UDI
Regulation Number
870.4075 FDA UDI
Market of Registration
Netherlands EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endomyocardial biopsy forceps, single-use

Jawz Endomyocardial Biopsy Forceps by Argon Medical Devices, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Endomyocardial biopsy forceps, single-use.

Cleared under the same submission

K951447 also covers:

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDD

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Argon Medical Devices, Inc.

Sources (3)

  • FDA UDI d2fdc27b-7ba2-4344-b5af-a3da4c47705d 37 fields · synced Jul 8, 2026
  • FDA UDI acfe2f45-1848-411d-b49d-d2ba926f3f3a 37 fields · synced May 30, 2026
  • EUDAMED 2f66231f-bbab-4283-86c8-aec49b89fedf 61 fields · synced Jul 8, 2026