FDA.reportPublic FDA data

IO-FLEX

Primary DI
00840916103811
Brand
IO-FLEX
Company
SPINAL ELEMENTS
Model
iO-DH
Device description
IO-Flex Distal Handle
Published
2017-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113533000NEURO CHECK DEVICE WITH IO-FLEX WIREBaxano, Inc.2012-04-11HAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840916103811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840916103811008409161038118409161038110840916103811

GMDN Terms#

Term, Definition table
TermDefinition
Nerve-locating probe, single-useA sterile, hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG)], by delivering controlled electrical impulses to a specific body site for the measurement of a nerve response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
004022104
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840916156176TALONTL22342020-05-05
00840916156183TALONTL22352020-05-05
00840916156190TALONTL22362020-05-05
00840916156206TALONTL22372020-05-05
00840916156213TALONTL22382020-05-05
00840916107208OMNICT050502017-06-19
00840916107215OMNICT050552017-06-19
00840916107253OMNICT060502017-06-19
00840916107291OMNICT070452017-06-19
00840916107307OMNICT070502017-06-19
00840916107987OMNILCPT 100-K2017-06-27
00840916108007OMNILCPT 120-K2017-06-27
00840916108014OMNILCPT 130-K2017-06-27
00840916108021OMNILCPT 140-K2017-06-27
00840916108038OMNILCPT 150-K2017-06-27
00840916108045OMNILCPT 35-K2017-06-28
00840916108052OMNILCPT 40-K2017-06-28
00840916108069OMNILCPT 45-K2017-06-28
00840916108076OMNILCPT 50-K2017-06-28
00840916108083OMNILCPT 55-K2017-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9228132210Surgical DirectSurgical Direct, Inc.HAE2026-10-20
B382SD9228132220Surgical DirectSurgical Direct, Inc.HAE2026-10-20
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