FDA.reportPublic FDA data

Entellus Medical Reinforced Anesthesia Needle

Primary DI
00857326005550
Brand
Entellus Medical Reinforced Anesthesia Needle
Company
ENTELLUS MEDICAL, INC.
Model
RAN
Catalog number
RAN-027-2
Device description
The Reinforced Anesthesia Needle is a disposable medical device that allows the user to transnasally administer anesthetic solutions. The needle may be reshaped along the 3.5” length.
Published
2017-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
00857326005550PrimaryGS10
10857326005557Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857326005550008573260055508573260055500857326005550
1085732600555710857326005557

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
017283879
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857326005536XeroGelXG-1022020-09-10
00857326005543XeroGelXG-1082020-09-10
10850002250210Shaver Blade 2.1mm Reusable Double Serrated StraightSSB-222-02020-09-25
10857326005731Shaver Blade 3mm Reusable Double Serrated Straight SSB-223-02020-09-25
10857326005748Shaver Blade 4mm Reusable Double Serrated Straight SSB-224-02020-09-25
10857326005755Shaver Blade 3mm Single Use Double Serrated StraightSSB-12300-1, SSB-12300-52020-09-25
10857326005762Shaver Blade 3mm Single Use Double Serrated 40° SSB-12340-1, SSB-12340-52020-09-25
10857326005779Shaver Blade 3mm Single Use Double Serrated 60°SSB-12360-1, SSB-12360-52020-09-25
10857326005786Shaver Blade 4mm Single Use Double Serrated Straight SSB-12400-1, SSB-12400-52020-09-25
10857326005793Shaver Blade 4mm Single Use Double Serrated 40° SSB-12440-1, SSB-12440-52020-09-25
10857326005809Shaver Blade 4mm Single Use Double Serrated 60° SSB-12460-1, SSB-12460-52020-09-25
10857326005830Shaver Blade 2.1mm Single Use Double Serrated StraightSSB-12200-1, SSB-12200-52020-09-25
00857326005574Entellus Medical Reinforced Anesthesia Needle RANRAN-027-52017-05-18
00857037006990LATERALATDD012016-07-21
00857037006983LATERALATANI012016-07-21
00857037006921LATERALATDD242017-09-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459468025MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-08-18
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M661S103418500Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C21600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C22200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S80C23200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S90C22600MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-06-18
08886479300252Reach NeedleAerin Medical Inc.BSP2024-06-10
M661S80C21200MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
M661S80C21400MSK Ultrasonic Injection NeedleSpectra Medical Devices, LLCBSP2024-02-12
00382904003715BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003722BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
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00382904003821BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
10193489250428Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
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10193489778083Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489902822Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10612479261003McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261034McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261065McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
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10612479261126McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261157McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10193489253023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2021-08-27
10193489550115MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-28
10193489270990MedlineMEDLINE INDUSTRIES, INC.BSP2021-01-27
10680651479096HalyardAvanos Medical, Inc.BSP2019-07-15
10680651477566HalyardAvanos Medical, Inc.BSP2019-06-15