FDA.reportPublic FDA data

Eclipse Needle

Primary DI
00382903032785
Brand
Eclipse Needle
Company
BECTON, DICKINSON AND COMPANY
Model
303278
Catalog number
303278
Device description
NEEDLE ECLIPSE 23X1-1/2 RB TW BNS
Published
2024-11-13
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

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
K161170000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161170000BD Eclipse Hypodermic NeedleBecton, Dickinson and Company2016-05-27FMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903032780PackageGS16500In Commercial Distribution
00382903032785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290303278050382903032780
00382903032785003829030327853829030327850382903032785

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
Length1.5Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

Regulatory Flags#

DUNS number
001292192
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02

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