Access Needle N10222300

GUDID 05711055000284

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 ID05711055000284
NIH Device Record Key07b26199-eb02-4eee-b35c-cd8882b37919
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccess Needle
Version Model NumberN10222300
Catalog NumberN10222300
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

Device Dimensions

Needle Gauge22 Gauge
Length30 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
GS105711055000284 [Package]
Contains: 15711055000281
Package: Retail Box [20 Units]
In Commercial Distribution
GS115711055000281 [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,

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