FDA.reportPublic FDA data

FIXOCATH

Primary DI
04048223018354
Brand
FIXOCATH
Company
Pajunk GmbH Medizintechnologie
Model
001151-37Z
Catalog number
001151-37Z
Device description
001151-37Z
Published
2021-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14048223018351PreviousGS10
04048223100370PrimaryGS10
04048223018354Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1404822301835114048223018351
04048223100370040482231003704048223100370
04048223018354040482230183544048223018354

GMDN Terms#

Term, Definition table
TermDefinition
Adhesive bandageA sterile piece of fabric or plastic material intended to be applied to a part of a patient's body and held in place by its pressure-sensitive adhesive to secure objects to the skin, cover and protect wounds, and/or approximate the skin edges of a wound; it may or may not include an absorbent pad. It is not intended for compression bandaging and is not an adhesive tape nor an adhesive strip (e.g., such as an Elastoplast or Band-aid brand). 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
317654283
Device count
10
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
04048223126103NerveStim Pure1151-94-901151-94-902026-02-06
04048223128817SPROTTE®511151-29A511151-29A2025-09-16
04048223129111SPROTTE® NRFit051163-29A051163-29A2025-09-16
04048223129517SPROTTE® NRFit041163-29A041163-29A2025-09-16
04048223129647SPROTTE®071151-30C071151-30C2025-09-16
04048223129678SPROTTE® NRFit021163-30C021163-30C2025-09-16
04048223129692SPROTTE® NRFit031163-27A031163-27A2025-09-16
04048223129838SPROTTE® NRFit061163-29A061163-29A2025-09-16
04048223129999Standard Sprotte Needle321151-29A321151-29A2025-09-16
04048223131398Standard Sprotte Needle341151-31B341151-31B2025-09-16
04048223131428SPROTTE®131151-30C131151-30C2025-09-16
04048223131442SPROTTE®131151-30A131151-30A2025-09-16
04048223131466SPROTTE®141151-30C141151-30C2025-09-16
04048223132050SonoPlex® II Facet S001287-72001287-722025-09-16
04048223132135SonoPlex® II Facet S001287-76001287-762025-09-16
04048223132241SonoPlex® II Facet NRFit001265-74001265-742025-09-16
04048223132319SonoPlex® II Facet NRFit001265-77001265-772025-09-16
04048223132395SonoPlex® II Facet001285-76001285-762025-09-16
04048223132463SonoBlock II Facet001280-74001280-742025-09-16
04048223132562SonoPlex® II Facet S NRFit001267-76001267-762025-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223128534StimuLong Sono II NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-07-30
04048223129456EpiLong TuohyPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223133385EpiSpin LockPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223133392EpiSpin LockPajunk GmbH MedizintechnologieCAZ2025-07-30
04048223128190SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128206SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128244StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128312SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128343PlexoLong NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128398SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128404SonoLong Curl EchoPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128435PlexoLong Sono NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128527SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128558StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128565SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128589SonoLong Echo NanoLine® NRFitPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128596SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128602SonoLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128626PlexoLong Sono NanoLine® acc. MeierPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128633StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128640SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128664SonoLong Curl EchoPajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128688SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128701SonoLong Echo NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128725StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128749StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128756StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128763StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128787StimuLong NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17
04048223128800StimuLong Sono NanoLine®Pajunk GmbH MedizintechnologieCAZ2025-06-17