FDA.reportPublic FDA data

Magellan

Primary DI
10884521201934
Brand
Magellan
Company
Cardinal Health, Inc.
Model
7777866215
Catalog number
7777866215
Device description
Magellan, Safety Needle, Cream Hub, 22 G x 1-1/2” (0.711 mm x 3.8 cm) TW, Caution: For processing, repacking or manufacturing
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMINeedle, hypodermic, single lumen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMINeedle, Hypodermic, Single LumenGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012736000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012736000MONOJECT SAFETY NEEDLETyco Healthcare2001-10-25FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521201934PrimaryGS10
20884521201931Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452120193410884521201934
2088452120193120884521201931

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length1.5Inch
Needle Gauge22Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
080935429
Device count
2000
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20884521148342Kendall22660A22660A2017-08-02
20884521148397Kendall31244422A31244422A2016-09-24
10884521007086Monoject118881811311888181132016-09-24
10884521007109Monoject118881910011888191002016-09-24
10884521007116Monoject118881911211888191122016-09-24
10884521007130Monoject118882011211888201122016-09-24
30884521024841Kendall923692362018-06-30
10884521156159Monoject8934CRS8934CRS2017-01-06
10884521156173Monoject8985CRH8985CRH2017-01-07
20884521156200Monoject8985CRS8985CRS2017-01-07
20884521156217Monoject8989CRH8989CRH2017-01-07
10884521010444Monoject888147127388814712732018-06-30
10884521157682Curity2022A2022A2018-06-22
10884521195547Monoject1180327114E1180327114E2018-06-22
20884521195506Monoject1180323114E1180323114E2018-06-22
40884521010438Monoject888147123288814712322018-06-30
40884521018311SharpSafety8535Y8535Y2017-01-07
40884521018380Monoject8970Y8970Y2017-01-06
10884521742390Monoject888135278888813527882019-05-17
10884527006786Monoject888135278888813527882016-09-24

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Primary DI, Brand, Company table
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00810011730816QikDiagTianjin Huahong Technology Co., Ltd.FMI2026-07-10
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20192253036982MonojectCardinal Health 200, LLCFMI2026-07-09
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