FDA.report

InfiltraLong set consisting of:

Primary DI
14048223016050
Brand
InfiltraLong set consisting of:
Company
Pajunk GmbH Medizintechnologie
Model
001158-30C
Catalog number
001158-30C
Device description
InfiltraLong set consisting of: InfiltraLong catheter 19G x 700mm with integrated metal spiral with 88 drill
Published
2016-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications

CodeDeviceSpecialtyClass
BSOCatheter, Conduction, AnestheticAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14048223016050PrimaryGS10
04048223016053Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1404822301605014048223016050
04048223016053040482230160534048223016053

GMDN Terms

TermDefinition
Anaesthesia conduction catheterization kitA collection of sterile devices and materials intended for the repeated or continuous injection of local anaesthetics for preoperative, intraoperative, or postoperative regional anaesthesia and/or pain management. The kit consists of an anaesthesia catheter with devices dedicated to catheter introduction/function (e.g., tunneller, needle, sheath) and includes non-dedicated supportive devices (e.g., dressings, adhesive strips). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)972-5865info@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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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