FDA.reportPublic FDA data

LOR 10ml

Primary DI
14048223012519
Brand
LOR 10ml
Company
Pajunk GmbH Medizintechnologie
Model
0001151-45
Catalog number
0001151-45
Device description
LOR 10ml Loss of resistance Syringe, sterile
Published
2016-09-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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
K060311000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060311000EPILONG KIT FOR ANESTHESIOLOGYPAJUNK GmbH Medizintechnologie2006-06-13CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223012519PrimaryGS10
04048223012512Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822301251914048223012519
04048223012512040482230125124048223012512

GMDN Terms#

Term, Definition table
TermDefinition
Low-resistance syringeA sterile, low-friction glass or plastic barrel (cylinder) with plunger intended to be used with a needle typically to locate the epidural space. The user advances the needle until a loss of resistance (LOR) is sensed in the plunger, indicating entry into the epidural space. The syringe may then be disconnected to allow the introduction of a catheter through the needle for diagnostic or therapeutic intervention. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)972-5865info@pajunk-usa.com

Regulatory Flags#

DUNS number
317654283
Device count
10
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048223122655Tuohy II1170-6I0911170-6I0912026-10-22
04048223122679Tuohy II1170-6K0811170-6K0812026-10-22
04048223122693Tuohy II1170-6K0911170-6K0912026-10-22
04048223122716Tuohy II1170-6K1201170-6K1202026-10-22
04048223122730Tuohy II1170-6M0811170-6M0812026-10-22
04048223122754Tuohy II1170-6M0911170-6M0912026-10-22
04048223122792Tuohy II1170-6O0811170-6O0812026-10-22
04048223122815Tuohy II1170-6O0911170-6O0912026-10-22
04048223122877Tuohy II NRFit1176-6I0911176-6I0912026-10-22
04048223122891Tuohy II NRFit1176-6K0811176-6K0812026-10-22
04048223122914Tuohy II NRFit1176-6K0911176-6K0912026-10-22
04048223122938Tuohy II NRFit1176-6K1201176-6K1202026-10-22
04048223122952Tuohy II NRFit1176-6M0811176-6M0812026-10-22
04048223122976Tuohy II NRFit1176-6M0911176-6M0912026-10-22
04048223122990Tuohy II NRFit1176-6M1201176-6M1202026-10-22
04048223123010Tuohy II NRFit1176-6O0811176-6O0812026-10-22
04048223123034Tuohy II NRFit1176-6O0911176-6O0912026-10-22
04048223124574Tuohy II NRFit1176-6K1031176-6K1032026-10-22
04048223124581Tuohy II NRFit1176-6M1031176-6M1032026-10-22
04048223124611Tuohy II1170-6M1201170-6M1202026-10-22

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Primary DI, Brand, Company table
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10801902228076ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10801902228083ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10801902228090ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
10801902228106ARROWTELEFLEX INCORPORATEDCAZ2026-10-09
00193493001088SINGLE SHOT EPIDURAL TRAYAvanos Medical, Inc.CAZ2026-08-21
10801902209471ARROWTELEFLEX INCORPORATEDCAZ2026-07-29
10801902217193ARROWTELEFLEX INCORPORATEDCAZ2026-07-29
15019517332063PortexICU MEDICAL, INC.CAZ2026-07-27
10801902202243ARROWTELEFLEX INCORPORATEDCAZ2026-07-13
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
10801902216486ARROWTELEFLEX INCORPORATEDCAZ2023-10-26
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