FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096403909
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
HTM0109-S01
Catalog number
HTM0109-S01
Device description
Prestige™ Fixed Handle T Medium ZSJH Cannulated Blk
Published
2020-05-29
Public version status
New
Distribution status
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
00840096403909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096403909008400964039098400964039090840096403909

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
00840096401332Viant Medical, LLCT11773T117732020-05-27
00840096401349Viant Medical, LLCT12673T126732020-05-27
00840096401356Viant Medical, LLCT13879T138792020-05-27
00840096401363Viant Medical, LLCT17712T177122020-05-27
00840096401387Viant Medical, LLCT2482T24822020-05-27
00840096401400Viant Medical, LLCT5326T53262020-05-27
00840096401417Viant Medical, LLCT16096T160962020-11-06
00840096401424Viant Medical, LLCT11774T117742020-05-27
00840096401431Viant Medical, LLCT12413T124132020-05-27
00840096401448Viant Medical, LLCT2227T22272020-05-27
00840096401455Viant Medical, LLC5140395140392020-05-27
00840096401462Viant Medical, LLCT2401T24012020-05-27
00840096401479Viant Medical, LLCT2947T29472020-05-27
00840096401486Viant Medical, LLCT8458T84582020-05-27
00840096401493Viant Medical, LLCT8059T80592020-05-27
00840096401509Viant Medical, LLCT2394T23942020-05-27
00840096401516Viant Medical, LLCT11775T117752020-05-27
00840096401523Viant Medical, LLCT12228T122282020-05-27
00840096401530Viant Medical, LLCT12283T122832020-05-27
00840096401547Viant Medical, LLCT15514T155142020-05-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506090998ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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00198506091025ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091032ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091049ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091056ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091063ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091070ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
00198506091087ELMED INCORPORATEDELMED INCORPORATEDLXH2026-05-26
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