FDA.reportPublic FDA data

NeuroTrace

Primary DI
B33955718090
Brand
NeuroTrace
Company
Neo Medical Inc.
Model
557-18-09
Catalog number
557-18-09
Device description
"Insulated Electro-Needle for use in Regional Anesthesia, 18ga x 3.5"" (89 mm), Tuohy Bevel"
Published
2016-09-24
Public version status
Update
Distribution status
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
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
B33955718095PackageHIBCC10In Commercial Distribution
B33955718090PrimaryHIBCC0

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
Length3.5Inch
Length89Millimeter
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
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
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B33919580060NeoMagic1958-0061958-0062026-03-27
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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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