Monoject SC3513X

GUDID 20884521021089

Snarecoil Bone Marrow Biopsy Needle

Cardinal Health, Inc.

Bone marrow biopsy needle, single-use
Primary Device ID20884521021089
NIH Device Record Key45c5b9ab-946a-4112-a491-b2d8276688f6
Commercial Distribution Discontinuation2021-02-17
Commercial Distribution StatusNot in Commercial Distribution
Brand NameMonoject
Version Model NumberSC3513X
Catalog NumberSC3513X
Company DUNS080935429
Company NameCardinal Health, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com
Phone+1(508)261-8000
Emailcovidien.udi@covidien.com

Device Dimensions

Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch
Device Size Text, specify0
Length3 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;
Special Storage Condition, SpecifyBetween 0 and 0 *;

Device Identifiers

Device Issuing AgencyDevice ID
GS110884521021082 [Primary]
GS120884521021089 [Package]
Contains: 10884521021082
Package: PACK_OR_INNER_PACK [10 Units]
Discontinued: 2021-02-17
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWINSTRUMENT, BIOPSY

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number7
Public Version Date2021-02-18
Device Publish Date2016-10-14

On-Brand Devices [Monoject]

30884527022742Insulin Syringe
30884527022735Insulin Syringe
20884527022721Insulin Syringe
20884527022714Insulin Syringe
00884521169541Insulin Syringe
00884521169527Insulin Syringe
00884521169503Insulin Syringe
20884527022677Insulin Syringe
30884527022667Insulin Syringe
00884521169442Insulin Syringe
10884527022649Insulin Syringe
20884521151847Insulin Syringe with Extra Fine Needle
20884521151830Insulin Syringe with Extra Fine Needle
20884521151823Insulin Syringe with Extra Fine Needle
30884521010431Endodontic Needle
208845210056900.9% Sodium Chloride,Flush Syringe, 2.5 mL Fill, Blunt Cannula
10884527017966Filter Needle,Aluminum Hub
20884527006752Blood Collection Tube,Silicone Coated Blue Stopper, Buffered Sodium Citrate 0.5 mL 3.2% Solution
10884527006632Blood Collection Tube,Silicone Coated Lavender Stopper, EDTA (K3) 0.05 mL 15.0% Solution, 5 mL D
108845211637060.9% Sodium Chloride,Flush Syringe, 2.5 mL Fill
108845211636900.9% Sodium Chloride,Flush Syringe, 5 mL Fill
108845211636830.9% Sodium Chloride,Flush Syringe, 3 mL Fill
108845211636760.9% Sodium Chloride,Flush Syringe, 10 mL Fill
20884521150093Blood Collection Tube,Glycerine Coated Lavender Stopper, EDTA (K3) 0.04 mL 15.0% Solution, 4.0 m
20884521102757Needleless Med Prep Cannula
20884521102498Enteral Syringe with Tip Cap
20884521082929Blunt Tip Cannula,Vial Access Pin
20884521082493Vial Access Cannula,Smart Tip
10884521082472Vial Access Combo,Blunt Tip
108845210150501 mL Insulin Syringe,Permanent Needle
208845210150331 mL Insulin Syringe,Permanent Needle
108845210150291 mL Insulin Syringe,Permanent Needle
108845210150053/10 mL Insulin Syringe,Permanent Needle
108845210149851/2 mL Insulin Syringe,Permanent Needle
108845210149231/2 mL Insulin Syringe,Permanent Needle
108845210149091/2 mL Insulin Syringe,Permanent Needle
10884521014480Safety Syringe Tip Cap
208845210139091/2 mL Tuberculin Syringe,Permanent Needle
20884521013077Blood Collection/Infusion Set,Female Luer, 12 inch (30.5 cm) Tubing
20884521012995Blood Collection/Infusion Set,Female Luer, 12 inch (30.5 cm) Tubing
20884521012971Blood Collection/Infusion Set,Female Luer, 12 inch (30.5 cm) Tubing
20884521008790Standard Hypodermic Needle,Aluminum Hub
20884521008752Standard Hypodermic Needle,Aluminum Hub
20884521008745Standard Hypodermic Needle,Aluminum Hub
20884521008707Standard Hypodermic Needle,Aluminum Hub
20884521008646Standard Hypodermic Needle,Aluminum Hub
20884521008585Standard Hypodermic Needle,Aluminum Hub
20884521008547Standard Hypodermic Needle,Aluminum Hub
20884521008431Standard Hypodermic Needle,Aluminum Hub
20884521008387Standard Hypodermic Needle,Aluminum Hub

Trademark Results [Monoject]

Mark Image

Registration | Serial
Company
Trademark
Application Date
MONOJECT
MONOJECT
74560228 2099750 Dead/Cancelled
SHERWOOD SERVICES AG
1994-08-08
MONOJECT
MONOJECT
74191238 1762511 Dead/Cancelled
Ecolab Inc.
1991-08-05
MONOJECT
MONOJECT
73569258 1403009 Live/Registered
SHERWOOD MEDICAL COMPANY
1985-11-18
MONOJECT
MONOJECT
73569236 1403008 Live/Registered
SHERWOOD MEDICAL COMPANY
1985-11-18
MONOJECT
MONOJECT
73170520 1124445 Dead/Cancelled
SHERWOOD MEDICAL INDUSTRIES INC.
1978-05-15
MONOJECT
MONOJECT
72037194 0664129 Dead/Expired
ROEHR PRODUCTS CO., INC.
1957-09-13

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