Access Needle N10222200

GUDID 05711055000260

Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy, PTC) preceding introduction of guidewires.

Mermaid Medical A/S

Interventional radiology percutaneous-access kit, single-use
Primary Device ID05711055000260
NIH Device Record Keya9251d2f-9af8-4d96-8b09-f0b5426b9a9d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Needle
Version Model NumberN10222200
Catalog NumberN10222200
Company DUNS308951313
Company NameMermaid Medical A/S
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+4547108570
Emailcustomer@mermaidmedical.com

Device Dimensions

Needle Gauge22 Gauge
Length20 Centimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 * Keep away from sunlight and keep dry

Device Identifiers

Device Issuing AgencyDevice ID
GS105711055000260 [Package]
Contains: 15711055000267
Package: Retail Box [20 Units]
In Commercial Distribution
GS115711055000267 [Primary]

FDA Product Code

GCBNeedle, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-10-10
Device Publish Date2019-08-05

On-Brand Devices [Access Needle]

05711055001922Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055001915Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055001908Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055000307Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055000291Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055000284Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055000277Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055000260Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055000086Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055000062Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,
05711055000055Puncture needle for use in accessing non-vascular accumulations (abscess puncture, nephrostomy,

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.