FDA.reportPublic FDA data

Halyard

Primary DI
10809160324318
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
RP1835D_0005
Catalog number
RP1835D
Published
2020-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

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
K854816000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K854816000EPIDURAL ANESTHESIA NEEDLESReganes, Inc.1985-12-19BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160324315PackageGS110In Commercial Distribution
10809160324318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916032431520809160324315
1080916032431810809160324318

GMDN Terms#

Term, Definition table
TermDefinition
Epidural needle, non-threadedA sterile, sharp bevel-edged, hollow tubular metal instrument designed to access the epidural space. It may be used to deliver anaesthetic or analgesic agents or to introduce a dedicated catheter for continuous anaesthesia administration. If used with a stylet, it is often referred to as a cannula. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(888) 564-7153PIQ@owens-minor.com

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160529188HalyardGBTK48-02_0005GBTK48-022026-08-07
10809160529195HalyardBKLS53-02_0004BKLS53-022026-08-07
10809160529201HalyardSGRB86-05_0011SGRB86-052026-08-07
10809160529218HalyardSGCB55-05_0001SGCB55-052026-08-07
10809160529225HalyardVMCC024-14_0008VMCC024-142026-08-07
10809160529232HalyardAKML42-02_0014AKML42-022026-08-07
10809160529249HalyardQPLP65-02_0004QPLP65-022026-08-07
10809160529256HalyardSFSAKML42-02_0001SFSAKML42-022026-08-07
10809160529263HalyardAKLE90-03_0002AKLE90-032026-08-07
10809160529270HalyardSFSAKLE90-03_0001SFSAKLE90-032026-08-07
10809160529287HalyardQPMN13-02_0011QPMN13-022026-08-07
10809160529294HalyardACTS62-02_0004ACTS62-022026-08-07
10809160529300HalyardACSH43-04_0002ACSH43-042026-08-07
10809160529317HalyardHVBM213-04_0004HVBM213-042026-08-07
10809160529324HalyardBMHT501-01_0011BMHT501-012026-08-07
10809160529331HalyardJACK428-07_0004JACK428-072026-08-07
10809160529348HalyardMSBM039-04_0004MSBM039-042026-08-07
10809160529355HalyardMCLP78-02_0007MCLP78-022026-08-07
10809160529362HalyardSELF134-05_0007SELF134-052026-08-07
10809160529379HalyardSELF133-07_0004SELF133-072026-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223139110CauDal SonoPajunk GmbH MedizintechnologieBSP2026-07-06
04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076347Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
10198459468025MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-08-18
M661S103417350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
M661S103418350Plastic BD Style Hub Tuohy Epidural NeedleSpectra Medical Devices, LLCBSP2024-06-18
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
00382904003739BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
00382904003821BD Whitacre SpinalBECTON, DICKINSON AND COMPANYBSP2023-09-02
05060498301626Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301657Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498301770Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498306898Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498306928Dash 6GBUK GROUP LIMITEDBSP2023-06-02
05060498307345Dash 6 NRFit™GBUK GROUP LIMITEDBSP2023-06-02
10193489250428Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489250510Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489778083Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04
10193489902822Medline Industries, Inc.MEDLINE INDUSTRIES, INC.BSP2022-08-04