FDA.reportPublic FDA data

MEDLINE INDUSTRIES, INC.

Primary DI
40888277832450
Brand
MEDLINE INDUSTRIES, INC.
Company
MEDLINE INDUSTRIES, INC.
Model
ULTRASTIM2102
Catalog number
ULTRASTIM2102
Device description
NDL, STIM AND ULTRA, 21G X 2"
Published
2025-12-18
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

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
K063380000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063380000ECHOSTIM FACET TIPHavel'S, Inc.2007-04-25BSP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40888277832450PackageGS125In Commercial Distribution
10888277832459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4088827783245040888277832450
1088827783245910888277832459

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral nerve-block sharp needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to invasively access a peripheral nerve to inject an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature. Avoid excessive heat. Shield from direct light.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196299850MEDLINEMSC9614EPMSC9614EP2026-10-22
10193489109702NAMICDYNJCAPMF1DYNJCAPMF12026-10-22
10884389119310MEDLINEMSC1513MSC15132026-10-22
10080196317462MEDLINEMSC1510MSC15102026-10-21
10884389111499MEDLINEMSC1528MSC15282026-10-21
10193489068245NAMIC90500050905000502023-12-21
10197344104178MEDLINEPIVBCA24056PIVBCA240562026-10-16
10197344174423MEDLINEDYNJP1048DYNJP10482026-10-16
10197344219254MEDLINEDYNDSCL1000RDYNDSCL1000R2026-10-16
20197344223333MEDLINEL2USA2XLL2USA2XL2026-10-16
20197344223340MEDLINEL2USA3XLL2USA3XL2026-10-16
20197344223357MEDLINEL2USALL2USAL2026-10-16
20197344223364MEDLINEL2USALFL2USALF2026-10-16
20197344223371MEDLINEL2USAXLL2USAXL2026-10-16
20197344225894MEDLINEDYND30363DYND303632026-10-16
10193489194531MEDLINEDYNDV2284DYNDV22842020-04-16
10193489194692MEDLINEDYNDV2310DYNDV23102020-04-16
10653160353577MEDLINEART1010BART1010B2022-05-31
10653160362074MEDLINEART20G17501ART20G175012023-07-21
10888277194847MedlineMDS9913DMMDS9913DM2016-10-14

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