FDA.reportPublic FDA data

Viant Medical, LLC

Primary DI
00840096400946
Brand
Viant Medical, LLC
Company
VIANT MEDICAL
Model
509576
Catalog number
509576
Device description
Blue Handle Curved Retractor
Published
2020-05-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096400946PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096400946008400964009468400964009460840096400946

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
100512072
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840096400045Viant Medical, LLC5111725111722020-09-29
00840096400069Viant Medical, LLCT17651T176512020-09-29
00840096403848Viant Medical, LLC5112725112722020-08-08
00840096403855Viant Medical, LLC5112735112732020-08-08
00840096401011Viant Medical, LLC5109125109122020-05-14
00840096401127Viant Medical, LLCT10491T104912020-05-14
00840096401141Viant Medical, LLCT12230T122302020-05-14
00840096401158Viant Medical, LLCT14174T141742020-05-14
00840096401165Viant Medical, LLCT14331T143312020-05-14
00840096401172Viant Medical, LLCT15752T157522020-05-14
00840096401189Viant Medical, LLCT16611T166112020-05-14
00840096401196Viant Medical, LLCT17703T177032020-05-14
00840096401233Viant Medical, LLCT8044T80442020-05-14
00840096401240Viant Medical, LLCT8088T80882020-05-14
00840096401257Viant Medical, LLCT8143T81432020-05-14
00840096401271Viant Medical, LLCT8177T81772020-05-14
00840096401288Viant Medical, LLCT8468T84682020-05-14
00840096401295Viant Medical, LLCT9316T93162020-05-14
00840096401042Viant Medical, LLCP290200-1206-091-122020-10-23
00840096401059Viant Medical, LLCP290300-1206-091-112020-10-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841731153104ARTEMIS FUZEVILEX LLCGAD2026-07-22
00841731153111ARTEMIS FUZEVILEX LLCGAD2026-07-22
B8038600980ORTHOMEDORTHO-MED, INC.GAD2026-07-22
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B803860120L0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
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B8039601370ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601390ORTHOMEDORTHO-MED, INC.GAD2026-07-22
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B803NL97010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL9701H0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
00190776402174MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403317MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403324MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403362MillenniumAvalign Technologies, Inc.GAD2026-07-21
00840183532185BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532192BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532222BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532239BR Surgical, LLCBR Surgical, LLCGAD2026-07-21