FDA.reportPublic FDA data

Modified Potts/Cournand Needle

Primary DI
00886333002887
Brand
Modified Potts/Cournand Needle
Company
ARGON MEDICAL DEVICES, INC.
Model
MPCN1802
Catalog number
MPCN1802
Device description
Modified Potts/Cournand Needle 18ga x 5.7cm
Published
2016-09-17
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974745000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974745000MANAN GWI GUIDE WIRE INTRODUCERMedical Device Technologies, Inc.1998-04-06DRC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20886333002881PackageGS125In Commercial Distribution
00886333002887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2088633300288120886333002881
00886333002887008863330028878863330028870886333002887

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, single-useA rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
1.800.927.4669Customer.Service@argonmedical.com

Regulatory Flags#

DUNS number
140727624
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886333003594Breast Localization Needles231075G231075G2022-07-05
00886333003600Breast Localization Needles231030G231030G2022-07-05
00886333003617Breast Localization Needles231050G231050G2022-07-05
00886333003624Breast Localization Needles231125G231125G2022-07-05
00886333003631Breast Localization Needles231100G231100G2022-07-05
00886333003648Breast Localization Needles2420502420502022-06-30
00886333003655Breast Localization Needles2420752420752022-06-30
00886333003662Breast Localization Needles2421002421002022-06-30
00886333003679Breast Localization Needles2421252421252022-06-29
00886333003686Breast Localization Needles2430752430752022-06-29
00886333003693Breast Localization Needles2431252431252022-07-05
00886333003709Breast Localization Needles2430502430502022-06-29
00886333003723Breast Localization Needles2430302430302022-06-29
00886333003730Breast Localization Needles2440302440302022-06-30
00886333003747Breast Localization Needles2440502440502022-06-30
00886333003754Breast Localization Needles2440752440752022-06-29
00886333003761Breast Localization Needles2441002441002022-06-30
00886333003778Breast Localization Needles2441252441252022-06-30
00886333003785Breast Localization Needles2511002511002022-06-29
00886333003792Breast Localization Needles2510752510752022-07-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810212933825SURGIPROSSurgipros, LLCDRC2026-07-28
00810212933832SURGIPROSSurgipros, LLCDRC2026-07-28
00810212933849SURGIPROSSurgipros, LLCDRC2026-07-28
00810212933856SURGIPROSSurgipros, LLCDRC2026-07-28
00841731135391Redemption VILEX LLCDRC2026-01-12
10192253057218ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057225ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057232ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057249ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057256ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057263ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253057287ArgyleCardinal Health 200, LLCDRC2024-08-02
10192253065237ArgyleCardinal Health 200, LLCDRC2024-08-02
00858769006425SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006449SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006456SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
00858769006470SafeSharp Transseptal NeedlePPMDMDRC2024-07-02
10884450412708Merit Advance®Merit Medical Systems, Inc.DRC2024-03-29
00858769006418SafeSept Transseptal GuidewirePPMDMDRC2022-09-26
00858769006364SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006371SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006388SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006395SafeSept Blunt NeedlePPMDMDRC2021-03-15
00858769006401SafeSept Blunt NeedlePPMDMDRC2021-03-15
M752TSBRF6640Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-10-26
M752TN170313069C0Stradis Medical, LLCSTRADIS MEDICAL LLCDRC2020-06-16
00849233009059Busse Hospital DiposablesROBERT BUSSE & CO., INC.DRC2020-04-08
00858769006197Transseptal NeedlePPMDMDRC2018-11-28
00858769006203Transseptal NeedlePPMDMDRC2018-11-28
00858769006210Transseptal NeedlePPMDMDRC2018-11-28