FDA.report

Temena

Primary DI
03700339703166
Brand
Temena
Company
Temena GmbH
Model
21951-21
Catalog number
21951-21
Device description
Pencil point spinal needle 21G x 90 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

Related Records

Product Codes

CodeName
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)

Product Code Classifications

CodeDeviceSpecialtyClass
BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)Anesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03700339703166PackageGS125In Commercial Distribution
03700339713530PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03700339703166037003397031663700339703166
03700339713530037003397135303700339713530

GMDN Terms

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

TypeValueUnit
Length90Millimeter
Needle Gauge21Gauge

Sterilization Methods

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 DIBrandModelCatalogPublished
03700339700141Temena01950-2001950-202017-11-28
03700339700158Temena01950-2201950-222017-11-28
03700339700165Temena01950-2401950-242017-11-20
03700339700172Temena01950-2501950-252017-11-28
03700339700189Temena01950-2601950-262017-11-20
03700339700196Temena01950-2701950-272017-11-28
03700339711253Temena21922-2721922-272017-11-29
03700339701292Temena21950-2221950-222017-11-28
03700339701308Temena21950-2421950-242017-11-20
03700339701315Temena21950-2521950-252017-11-28
03700339701322Temena21950-2621950-262017-11-28
03700339701339Temena21950-2721950-272017-11-28
03700339701346Temena21950-2921950-292017-11-28
03700339701353Temena21951-2221951-222017-11-20
03700339701360Temena21951-2421951-242017-11-28
03700339711376Temena21951-2521951-252017-11-28
03700339701384Temena21951-2621951-262017-11-28
03700339701391Temena21951-2721951-272017-11-28
03700339701551Temena29922-2729922-272017-11-29
03700339701599Temena31922-2731922-272017-11-29

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40888277832443MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
40888277832467MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
40888277832450MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.BSP2025-12-18
10193494001695PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001701PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001718PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001725PROBLOC* II Insulated Regional Block NeedleAvanos Medical, Inc.BSP2025-12-08
10193494001732PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001749PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001756PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001763PROBLOC* II Insulated Regional block NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001770ECHOBRIGHT* ECHOGENIC Single Shot Tuohy Needle with Stimulating CableAvanos Medical, Inc.BSP2025-11-28
10193494001787ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001794ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001800ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001817ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001824ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001831ECHOBRIGHT* ECHOGENIC Regional Block Needle with Injection SetAvanos Medical, Inc.BSP2025-11-28
10193494001848ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001855ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001862ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001879ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001886ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001893ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001909ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC NeedleAvanos Medical, Inc.BSP2025-11-28
10193494001916PROLONG* Continuous Nerve Block SetAvanos Medical, Inc.BSP2025-11-28
10193494001923PROLONG* Continuous Nerve Block SetAvanos Medical, Inc.BSP2025-11-28