FDA.reportPublic FDA data

Avalign

Primary DI
00190776040369
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM29-3182
Device description
Wylie Renal Vein Retractor
Published
2021-11-03
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGNRETRACTOR, NON-SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776040369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776040369001907760403691907760403690190776040369

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

Contacts#

Phone, Email table
PhoneEmail
+1(877)289-1096product.questions@avalign.com

Regulatory Flags#

DUNS number
792528510
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
false
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
00190776417895Millennium72-53030126C2026-03-23
00190776417901Millennium72-3280326I2026-03-23
00190776417918Millennium72-235613LH2026-03-23
00190776417925Millennium72-3752532026-03-23
00190776417932Millennium100-S03681TRS2026-03-23
00190776417949Millennium72-235633LH2026-03-23
00190776417956Millennium72-5225532B2026-03-23
00190776417963Millennium72-2407032026-03-23
00190776417970Millennium72-4071222026-03-23
00190776417987Millennium1-2236262026-03-23
00190776417994Millennium1-1281562026-03-23
00190776418007Millennium1-OP3702026-03-23
00190776418014Millennium1-7063104R2026-03-23
00190776418021Millennium72-3160021FSYR2026-03-23
00190776418038Millennium1-8207-92026-03-23
00190776418045Millennium1-161762026-03-23
00190776418052Millennium1-3011172026-03-23
00190776418069Millennium1-4301632026-03-23
00190776418076Millennium72-31578452026-03-23
00190776418267Millennium72-24026202026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811023018INKAThe Trustee for KAISER FAMILY TRUSTFGN2026-03-16
B382SD1471020010Surgical DirectSurgical Direct, Inc.FGN2026-02-16
B382SD934117790Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117800Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117810Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117820Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD934117830Surgical DirectSurgical Direct, Inc.FGN2025-09-17
B382SD711510000Surgical DirectSurgical Direct, Inc.FGN2025-08-11
B382SD722510000Surgical DirectSurgical Direct, Inc.FGN2025-08-11
B382SD914781140Surgical DirectSurgical Direct, Inc.FGN2025-07-23
B382SD914173650Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417810000Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417810010Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD91417811010Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD9141801050Surgical DirectSurgical Direct, Inc.FGN2025-07-10
B382SD4834150Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4861300Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4861400Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4862150Surgical DirectSurgical Direct, Inc.FGN2025-07-02
B382SD4871160Surgical DirectSurgical Direct, Inc.FGN2025-07-02
00810123209361Adler Instrument CompanyAdler, Inc.FGN2025-05-23
B382SD147091530Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691000Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691010Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691020Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD9190691030Surgical DirectSurgical Direct, Inc.FGN2025-04-07
B382SD1417812200Surgical DirectSurgical Direct, Inc.FGN2025-02-20
B382SD1417812310Surgical DirectSurgical Direct, Inc.FGN2025-02-20
00840319757611Hayden MedicalHayden Medical, Inc.FGN2025-01-10
00840319757628Hayden MedicalHayden Medical, Inc.FGN2025-01-10