FDA.reportPublic FDA data

Avalign

Primary DI
00190776043032
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM101-5536
Device description
Endaural Retractor
Published
2023-09-28
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
KALRETRACTOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776043032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776043032001907760430321907760430320190776043032

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
00190776416461MillenniumAvalign Technologies, Inc.KAL2026-02-16
00757770684304Bausch + LombBausch & Lomb IncorporatedKAL2025-08-05
00757770403011Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770412280Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770419425Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770419579Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770432486Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770414987Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770422050Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770423705Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770424603Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770428625Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
07899798208858QuinelatoSchobell Industrial LtdaKAL2025-02-27
00810123208395Adler Instrument CompanyAdler, Inc.KAL2025-01-27
00810123208203Adler Instrument CompanyAdler, Inc.KAL2025-01-10
00757770402526Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770402762Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770405343Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770405718Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770405848Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770406890Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770409310Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770410620Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770413799Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770414079Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770414277Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770419371Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770419463Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770420407Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770420421Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21