FDA.reportPublic FDA data

NeuroTrace

Primary DI
B33955718055
Brand
NeuroTrace
Company
NEO MEDICAL INC.
Model
557-18-05
Catalog number
557-18-05
Device description
Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 2.0" (51mm), Tuohy Bevel
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K994059000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K994059000CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07Hdc Corp.2000-10-13CAZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B33955718055PackageHIBCC10In Commercial Distribution
B33955718050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral anaesthesia catheter set, non-medicatedA collection of devices intended for the continuous-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block. It includes an anaesthesia needle and an anaesthesia catheter usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length2Inch
Length51Millimeter
Needle Gauge18Gauge

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away From Sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-450-3334support@neomedicalinc.com

Regulatory Flags#

DUNS number
015510540
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
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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B33919580060NeoMagic1958-0061958-0062026-03-27
B33919670010NeoMagic1967-0011967-0012026-03-27
B33919770010NeoMagic1977-0011977-0012026-03-27
B33919800010V-Cath1980-0011980-0012026-03-27
B339252526500NeoMagic2525-26502525-26502025-08-18
B339252526505NeoMagic2525-26502525-26502025-08-18
B339194316060NeoMagic1943-16061943-16062016-09-24
B339194316080NeoMagic1943-16081943-16082016-09-24
B339194316250NeoMagic1943-16251943-16252016-09-24
B339194316400NeoMagic1943-16401943-16402016-09-24
B339194416250NeoMagic1944-16251944-16252016-09-24
B339194416300NeoMagic1944-16301944-16302025-01-08
B339194416400NeoMagic1944-16401944-16402016-09-24
B339194416500NeoMagic1944-16501944-16502025-01-08
B339194616060NeoMagic1946-16061946-16062022-03-11
B339194616080NeoMagic1946-16081946-16082022-03-11

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