FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096400885
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
T105429
Catalog number
T105429
Device description
3.5 Hex Screwdriver with O-ring
Published
2020-05-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096400885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096400885008400964008858400964008850840096400885

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
100512072
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840096401318Viant Medical, LLC51277900-2360-080-002020-10-23
00840096401325Viant Medical, LLC51289600-2360-080-052020-10-23
00840096403787Viant Medical, LLC32-42299132-4229912020-10-23
00840096410051Viant Medical, LLCT394300-7803-095-432020-10-23
00840096410068Viant Medical, LLCT394400-7803-095-442020-10-23
00840096410075Viant Medical, LLCT394500-7803-095-452020-10-23
00840096410082Viant Medical, LLCT394600-7803-095-462020-10-23
00840096410099Viant Medical, LLCT394700-7803-095-472020-10-23
00840096410105Viant Medical, LLCT394800-7803-095-482020-10-23
00840096410112Viant Medical, LLCT394900-7803-095-492020-10-23
00840096410129Viant Medical, LLCT395000-7803-095-502020-10-23
00840096410136Viant Medical, LLCT395100-7803-095-512020-10-23
00840096410143Viant Medical, LLCT395200-7803-095-522020-10-23
00840096410150Viant Medical, LLCT395300-7803-095-532020-10-23
00840096410167Viant Medical, LLCT395400-7803-095-542020-10-23
00840096410174Viant Medical, LLCT395500-7803-095-552020-10-23
00840096410181Viant Medical, LLCT395600-7803-095-562020-10-23
00840096410198Viant Medical, LLCT395700-7803-095-572020-10-23
00840096410204Viant Medical, LLCT395800-7803-095-582020-10-23
00840096410211Viant Medical, LLCT395900-7803-095-592020-10-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M697X06402401Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.HXX2026-10-14
B382SD1455810020Surgical DirectSurgical Direct, Inc.HXX2026-09-29
B382SD1455810030Surgical DirectSurgical Direct, Inc.HXX2026-09-29
10886982345462VOLTSynthes GmbHHXX2026-09-25
00840606197342OmegaSPINAL ELEMENTS, INC.HXX2026-09-22
07640139343185BAGUERA C INSTRUMENTATIONSpineArt SAHXX2026-08-27
00843210143644Monaco Pedicle Screw SystemAltus Spine, LLCHXX2026-08-24
00199150083091Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-08-22
B095329646Hintermann SeriesDt Medtech, LLCHXX2026-08-21
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00840606191951Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
00840606191982Overwatch PCFSPINAL ELEMENTS, INC.HXX2026-07-31
03701089540643AMPLITUDEAMPLITUDE SASHXX2026-07-29
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03700569680299Newclip InstrumentsNEWCLIP TECHNICSHXX2026-07-28
00824846003199Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26
00824846003205Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXX2026-07-26