FDA.reportPublic FDA data

Nex-D2

Primary DI
00840314141811
Brand
Nex-D2
Company
NEXT ORTHOSURGICAL, INC.
Model
CBZB002-500
Catalog number
CBZB002-500
Device description
GUIDE WIRE, 1.4MM X 500MM
Published
2025-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314141811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314141811008403141418118403141418110840314141811

GMDN Terms#

Term, Definition table
TermDefinition
Spinal guidewireA thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length500Millimeter
Outer Diameter1.4Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
760-295-3600Info@nextorthosurgical.com

Regulatory Flags#

DUNS number
046767258
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314141798Nex-D2CBCAJ-10000CBCAJ-100002024-09-16
00840314141804Nex-D2CBCBJ-10000CBCBJ-100002024-09-16
00840314165923Nex-D2CBFBJ-70140CBFBJ-701402024-09-05
00840314165930Nex-D2CBFBJ-70145CBFBJ-701452024-09-05
00840314165947Nex-D2CBFBJ-70150CBFBJ-701502024-09-05
00840314165954Nex-D2CBFBJ-78020CBFBJ-780202024-09-05
00840314165961Nex-D2CBFBJ-78025CBFBJ-780252024-09-05
00840314165978Nex-D2CBFBJ-78030CBFBJ-780302024-09-05
00840314165985Nex-D2CBFBJ-78035CBFBJ-780352024-09-05
00840314165992Nex-D2CBFBJ-78040CBFBJ-780402024-09-05
00840314166005Nex-D2CBFBJ-78045CBFBJ-780452024-09-05
00840314166012Nex-D2CBFBJ-78050CBFBJ-780502024-09-05
00840314166029Nex-D2CBFBJ-78055CBFBJ-780552024-09-05
00840314166036Nex-D2CBFBJ-78060CBFBJ-780602024-09-05
00840314166043Nex-D2CBFBJ-78065CBFBJ-780652024-09-05
00840314166050Nex-D2CBFBJ-78070CBFBJ-780702024-09-05
00840314166067Nex-D2CBFBJ-78075CBFBJ-780752024-09-05
00840314166074Nex-D2CBFBJ-78080CBFBJ-780802024-09-05
00840314166081Nex-D2CBFBJ-78085CBFBJ-780852024-09-05
00840314166098Nex-D2CBFBJ-78090CBFBJ-780902024-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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