FDA.reportPublic FDA data

Reinforced Anesthesia Needle

Primary DI
10857326005571
Brand
Reinforced Anesthesia Needle
Company
STRYKER CORPORATION
Model
RAN-027-5
Device description
Reinforced anesthesia needle 5 pack
Published
2017-05-18
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
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163435000Entellus Medical Reinforced Anesthesia NeedleEntellus Medical, Inc.2017-04-05BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857326005571PrimaryGS10
00857326005574Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085732600557110857326005571
00857326005574008573260055748573260055740857326005574

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196548481
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327623338AXS LiftLIFT074095-01LIFT074095-012025-03-04
07613327623352AXS LiftLIFT074105-01LIFT074105-012025-03-04
07613327623376AXS LiftLIFT074110-01LIFT074110-012025-03-04
07613327623390AXS LiftLIFT074115-01LIFT074115-012025-03-04
07613327060027Precision Ideal Eyes05028190300502-819-0302016-09-23
07613327060072Precision Ideal Eyes05028230300502-823-0302016-09-23
07613327060102Precision Ideal Eyes05028231300502-823-1302016-09-23
07613327060119Precision Ideal Eyes05028270100502-827-0102016-09-23
07613327060126Precision Ideal Eyes05028230700502-823-0702016-09-23
07613327060140Precision Ideal Eyes05028270700502-827-0702016-09-23
07613327060157Precision Ideal Eyes05028271300502-827-1302016-09-23
07613327060164Precision Ideal Eyes05028270300502-827-0302016-09-23
07613327060232Precision Ideal Eyes05028230100502-823-0102016-09-23
07613327063875Precision Ideal Eyes, Speed-Lock05029270100502-927-0102016-09-23
07613327063882Precision Ideal Eyes, Speed-Lock05029270300502-927-0302016-09-23
07613327063899Precision Ideal Eyes, Speed-Lock05029270700502-927-0702016-09-23
07613327681741N/A48110005481100052025-09-03
07613327681727N/A48110004481100042025-09-03
07613327681758N/A48110006481100062025-09-03
37613327566162Neptune075020000007502000002024-10-15

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