FDA.reportPublic FDA data

Temena

Primary DI
03700339701315
Brand
Temena
Company
Temena GmbH
Model
21950-25
Catalog number
21950-25
Device description
Pencil point spinal needle 25G x 103 mm with introducer
Published
2017-11-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700339701315PackageGS125In Commercial Distribution
03700339711314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700339701315037003397013153700339701315
03700339711314037003397113143700339711314

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length103Millimeter
Needle Gauge25Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
329515725
Device count
1
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
03700339710140Temena01950-2001950-202017-11-28
03700339710157Temena01950-2201950-222017-11-28
03700339710164Temena01950-2401950-242017-11-20
03700339710171Temena01950-2501950-252017-11-28
03700339710188Temena01950-2601950-262017-11-20
03700339710195Temena01950-2701950-272017-11-28
03700339711291Temena21950-2221950-222017-11-28
03700339711307Temena21950-2421950-242017-11-20
03700339711314Temena21950-2521950-252017-11-28
03700339711321Temena21950-2621950-262017-11-28
03700339711338Temena21950-2721950-272017-11-28
03700339711345Temena21950-2921950-292017-11-28
03700339711352Temena21951-2221951-222017-11-20
03700339711369Temena21951-2421951-242017-11-28
03700339711383Temena21951-2621951-262017-11-28
03700339711390Temena21951-2721951-272017-11-28
03700339711550Temena29922-2729922-272017-11-29
03700339711598Temena31922-2731922-272017-11-29
03700339711604Temena31940-2231940-222017-11-28
03700339711611Temena31940-2431940-242017-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198459468025MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-08-18
08886479300252Reach NeedleAerin Medical Inc.BSP2024-06-10
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
10612479261003McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261034McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261065McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
10612479261096McKessonMCKESSON MEDICAL-SURGICAL INC.BSP2022-07-19
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
10680651478181HalyardAvanos Medical, Inc.BSP2019-06-15
10680651478785HalyardAvanos Medical, Inc.BSP2019-06-15
10680651476439HalyardAvanos Medical, Inc.BSP2019-02-21
10680651477061HalyardAvanos Medical, Inc.BSP2019-02-21
10680651477474HalyardAvanos Medical, Inc.BSP2019-02-21
10680651476422HalyardAvanos Medical, Inc.BSP2019-01-23
10680651476118HalyardAvanos Medical, Inc.BSP2019-01-11
10680651475630HalyardAvanos Medical, Inc.BSP2018-11-13
10680651475142HalyardAvanos Medical, Inc.BSP2018-09-23
10680651475036HalyardAvanos Medical, Inc.BSP2018-07-25
10680651474978HalyardAvanos Medical, Inc.BSP2018-07-13
10680651474688HalyardAvanos Medical, Inc.BSP2018-06-22
10680651474275HalyardAvanos Medical, Inc.BSP2018-05-10