Halyard

Primary DI
10809160323687
Brand
Halyard
Company
AVID MEDICAL, INC.
Model
RMPS2503_0005
Catalog number
RMPS2503
Published
2020-12-11
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MIANEEDLE, SPINAL, SHORT TERM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MIANeedle, Spinal, Short TermAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K971645000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K971645000REGANES SPINAL NEEDLE (VARIOUS)Avid N.I.T., Inc.1997-08-01MIA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160323684PackageGS110In Commercial Distribution
10809160323687PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916032368420809160323684
1080916032368710809160323687

GMDN Terms#

Term, Definition table
TermDefinition
Spinal needle, single-useA sharp bevel-edged, hollow tubular instrument designed for short-term use to withdraw a sample of cerebrospinal fluid (CSF), assist introduction of a spinal guidewire or catheter (e.g., lumboperitoneal shunt, intrathecal catheter), and/or deliver contrast media and/or anaesthetic or analgesic agents intrathecally (subarachnoid) or into a vertebral disc, either directly or using the needle-through-needle technique. It is typically fenestrated, spring-tipped, and made of metal and/or plastic materials; some types may be semi-rigid and include a stylet for support during handling. 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
10809160528365HalyardPSJH0015-02_0014PSJH0015-022026-08-03
10809160528372HalyardSFSAKOR36-02_0001SFSAKOR36-022026-08-03
10809160528389HalyardAKOR36-03_0002AKOR36-032026-08-03
10809160528396HalyardAKCR19-03_0003AKCR19-032026-08-03
10809160528402HalyardBMHT500-03_0005BMHT500-032026-08-03
10809160528419HalyardBMHU006-07_0007BMHU006-072026-08-03
10809160528426HalyardSELF137-05_0005SELF137-052026-08-03
10809160528433HalyardLANC039-31_0002LANC039-312026-08-03
10809160528440HalyardBMHT202-05_0004BMHT202-052026-08-03
10809160528457HalyardBMHT401-04_0006BMHT401-042026-08-03
10809160528464HalyardESCC82-02_0010ESCC82-022026-08-03
10809160528471HalyardLANC015-35_0011LANC015-352026-08-03
10809160528488HalyardBMHT400-03_0013BMHT400-032026-08-03
10809160528495HalyardBAMW001-03_0002BAMW001-032026-08-03
10809160528501HalyardQPTH29-02_0007QPTH29-022026-08-03
10809160528518HalyardSFSBMHU006-07_0001SFSBMHU006-072026-08-03
10809160528525HalyardHVBM219-04_0005HVBM219-042026-08-03
10809160528532HalyardSFSBAMW001-03_0001SFSBAMW001-032026-08-03
10809160528549HalyardMEEN42-03_0007MEEN42-032026-08-03
10809160528556HalyardDAMH300-03_0005DAMH300-032026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818788023698Epimed International, Inc.EPIMED INTERNATIONAL, INCMIA2022-05-05
10818788023695Epimed International, Inc.EPIMED INTERNATIONAL, INCMIA2022-05-05
10809160323502HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323618HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323625HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323632HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323649HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323656HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323663HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323670HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323694HalyardAVID MEDICAL, INC.MIA2020-12-11
10809160323700HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323509HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323615HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323622HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323639HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323646HalyardAVID MEDICAL, INC.MIA2020-12-11
20809160323653HalyardAVID MEDICAL, INC.MIA2020-12-11
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15019517070576PortexICU MEDICAL, INC.MIA2020-03-09
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