FDA.reportPublic FDA data

EPISPIN

Primary DI
04048223051979
Brand
EPISPIN
Company
Pajunk GmbH Medizintechnologie
Model
0021351-20
Catalog number
0021351-20
Device description
0021351-20
Published
2021-04-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CAZAnesthesia conduction kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAZAnesthesia Conduction KitAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060563000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060563000EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IVPajunk GmbH2006-06-02CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223009403PreviousGS10
04048223051979PrimaryGS10
04048223009406Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822300940314048223009403
04048223051979040482230519794048223051979
04048223009406040482230094064048223009406

GMDN Terms#

Term, Definition table
TermDefinition
Epidural/intrathecal anaesthesia set, non-medicatedA dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe) and may include an epidural catheter for continuous-administration. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity65 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1 770-493-6832info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223049860MANOMETER001163-38F001163-38F2021-04-02
04048223050163RFTL001165-20C001165-20C2021-04-02
04048223050248RFTL001165-30D001165-30D2021-04-02
04048223051757SONOPLEX001285-71001285-712021-04-02
04048223051801SONOPLEX001285-77001285-772021-04-02
04048223052303RFTL011165-40D011165-40D2021-04-02
04048223102541UNIPLEX® NANOLINE001156-72001156-722021-04-02
04048223102572UNIPLEX® NANOLINE001156-77001156-772021-04-02
04048223103319SONOBLOCK001180-71001180-712021-04-02
04048223103449SONOPLEX001185-71001185-712021-04-02
04048223103463SONOPLEX001185-74001185-742021-04-02
04048223103562SONOPLEX001187-74001187-742021-04-02
04048223107058SONOTAP1185-3E0501185-3E0502021-04-02
04048223115756TUOHY1150-7G1031150-7G1032021-07-07
04048223116043SONO MSK1191-4C0501191-4C0502021-07-07
04048223116074SONO MSK1191-4E0701191-4E0702021-07-07
04048223116081SONO MSK1191-4E0901191-4E0902021-07-07
04048223116098SONO MSK1191-4E1001191-4E1002021-07-07
04048223116265SONOTAP II1285-3E0501285-3E0502021-07-07
04048223116272SONOTAP II1285-3E0801285-3E0802021-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223070116UniPlex® NanoLine®Pajunk GmbH MedizintechnologieCAZ2026-06-10
04048223073056EpiLong CathPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223074787EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223074800EpiSpin Safety NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223084182EpiLong NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088005SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088050PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088661SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088692SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088708PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223088722PlexoLong NanoLine® NRFit acc. MeierPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223089873LOR NRFit 10ml, SlipPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223090466EpiLong CathPajunk GmbH MedizintechnologieCAZ2026-06-10
04048223125267SonoLong SoftSecurePajunk GmbH MedizintechnologieCAZ2026-06-10
10193489490312Medline Industries, Inc.MEDLINE INDUSTRIES, INC.CAZ2022-08-04
10193489031768MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031775MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031782MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
10193489031799MedlineMEDLINE INDUSTRIES, INC.CAZ2022-03-04
04048223116869PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223116883PLEXOLONGPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117088STIMULONG SONOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117187PLEXOLONG NANOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117309SONOLONG ECHOPajunk GmbH MedizintechnologieCAZ2021-07-07
04048223117422SONOLONG ECHOPajunk GmbH MedizintechnologieCAZ2021-07-07
10381780464792Integra®INTEGRA PAIN MANAGEMENTCAZ2018-07-16
10381780429531Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431640Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431657Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22
10381780431749Integra®INTEGRA PAIN MANAGEMENTCAZ2018-06-22