FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096403732
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
RTS0003-P-S09
Catalog number
RTS0003-P-S09
Device description
Prestige™ Ratchet Handle T Short 1/4" Square Plug Blue
Published
2020-05-13
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
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
00840096403732PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096403732008400964037328400964037320840096403732

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810161900015EARP DISC SPACER INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900022EARP INITIAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900039EARP FINAL INSERTERRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900046RETRACTABLE OSTEOTOMERETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900053EARP BLADE 100RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900060EARP BLADE 110RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900077EARP BLADE 120RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900084EARP BLADE 130RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900091EARP BLADE 140RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900107EARP BLADE 150RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900114EARP BLADE 160RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900121EARP BLADE 170RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900138EARP BLADE 180RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900145EARP BLADE 190RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900152EARP CRADLE ASSEMBLYRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900169EARP RETRACTOR CONNECTORRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900176EARP RETRACTOR TILT REPLACEMENTRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900183EARP CUFF TRIAL 3&4MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900190EARP CUFF TRIAL 5&6MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900206EARP, TRIAL 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900213EARP, TRIAL 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900220EARP, TRIAL 14X35X10 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900237EARP, TRIAL 18X35X8 0°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900244EARP, TRIAL 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900251EARP, TRIAL 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900268EARP, TRIAL 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900275EARP, TRIAL 18X35X12 12°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900282EARP, TRIAL 18X35X12 14°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900299EARP, TRIAL 22X35X10 6°RETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15
00810161900343EARP DISC SPACER, 8MMRETROPSOAS TECHNOLOGIES, LLCLXH2026-10-15