FDA.reportPublic FDA data

HMG Spinal Needle

Primary DI
10850048235158
Brand
HMG Spinal Needle
Company
Hartman Medical Group LLC
Model
SPN20G35QNS
Catalog number
SPN20G35QNS
Device description
Spinal Needle, 20G Non-sterile
Published
2025-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K212982000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212982000Medispine - Spinal Needle, Glospine - Spinal NeedleGlobal Medikit Limited2022-07-29BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850048235158PrimaryGS10
00850048235151Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004823515810850048235158
00850048235151008500482351518500482351510850048235151

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
117654675
Device count
100
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850048235196HMG Needleless PRN connectorCV22026-07-31
10850048235264HMG IV Administration SetGCA10010NF2026-07-31
20850048235193HMG Needleless PRN connectorCV22026-07-31
10850048235202HMG IV extension sets- CIV007CIV0072026-05-20
10850048235219HMG IV extension sets- CIV015CIV0152026-05-20
10850048235226HMG IV extension sets- CIV030CIV0302026-05-20
10850048235233HMG IV Administration SetGCA92102026-05-20
10850048235240HMG IV Administration SetGCA9210NF2026-05-20
10850048235257HMG IV Administration SetGCA35102026-05-20
20850048235209HMG IV extension sets- CIV007CIV0072026-05-20
20850048235216HMG IV extension sets- CIV015CIV0152026-05-20
20850048235223HMG IV extension sets- CIV030CIV0302026-05-20
10850048235172HMG Pump Driven IV Administration SetPCA10012026-05-19
10850048235189HMG Pump Driven IV Administration SetPCA10022026-05-19
40850048235098HMG IV extension set CV200BCV200B2025-10-30
50850048235088HMG IV extension Sets CV100RCV100R2025-10-30
70850048235068HMG IV Extension Set CV100BCV100B2025-10-30
70850048235075HMG IV extension sets- CVM100BCVM100B2025-10-30
80850048235072HMG IV extension sets- CVM100BCVM100B2025-10-30
20850048235155HMG Spinal NeedleSPN20G35QNSSPN20G35QNS2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223122655Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122679Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122693Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122716Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122730Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122754Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122792Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122815Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122877Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122891Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122914Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122938Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122952Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122976Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223122990Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223123010Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223123034Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124574Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124581Tuohy II NRFitPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124611Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124628Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223124635Tuohy IIPajunk GmbH MedizintechnologieBSP2026-10-22
04048223134030SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134054SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134078SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223134092SonoPlex® II SuperCutPajunk GmbH MedizintechnologieBSP2026-08-27
04048223139110CauDal SonoPajunk GmbH MedizintechnologieBSP2026-07-06
04048223070499NerveGuard NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076217Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10
04048223076248Quincke NRFitPajunk GmbH MedizintechnologieBSP2026-06-10