FDA.report

AVANOS

Primary DI
10193493442000
Brand
AVANOS
Company
Avanos Medical, Inc.
Model
CRK-17-75-5.5
Catalog number
CRK-17-75-5.5
Device description
COOLIEF* Cooled Radiofrequency Probe Kit
Published
2020-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXIProbe, radiofrequency lesion

Product Code Classifications

CodeDeviceSpecialtyClass
GXIProbe, Radiofrequency LesionNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10193493442000PackageGS12In Commercial Distribution
00193493442003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1019349344200010193493442000
00193493442003001934934420031934934420030193493442003

GMDN Terms

TermDefinition
Neurosurgical procedure kit, non-medicated, single-useA collection of various sterile neurosurgical instruments, dressings and the necessary materials used to perform a neurosurgical procedure. It does not contain pharmaceuticals. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(844)428-2667PIQ@AVANOS.COM

Regulatory Flags

DUNS number
079375431
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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10193494001756PROBLOC* II Insulated Regional block Needle120008755HN2-402025-11-28
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10193494001886ECHOLONG* Continuous Nerve Block Set with Insulated ECHOGENIC Needle120008750ELL18100TG2025-11-28

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