FDA.reportPublic FDA data

Avalign

Primary DI
00190776042479
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM101-9111
Device description
Shea Speculum Holder
Published
2023-06-23
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
FXGSPECULA ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXGSpecula AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776042479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776042479001907760424791907760424790190776042479

GMDN Terms#

Term, Definition table
TermDefinition
Ear speculum, reusableA rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. 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
00850071684308REALSTAR SURGICAL INSTRUMENTSREAL STAR SURGICAL INSTRUMENTSFXG2025-09-09
04030155000774Reusable ear funnels Ø 4.0 mm, 10 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2024-07-24
00840183503987BR Surgical, LLCBR Surgical, LLCFXG2024-02-06
00190776317799MillenniumAvalign Technologies, Inc.FXG2023-11-13
04030155000613Ear funnel, black, small Ø 2.5 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000637Ear funnel, black, large Ø 4.0 mm, in units of 100 pcs.Kirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000651Ear funnel, grey, small Ø 2.5 mm, 10 x 100 pcs. in polybagKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000668Ear funnel, small, grey, Ø 2.5 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000682Ear funnel, grey, large Ø 4.0 mm, 10x100 pcs. in polybagKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
04030155000699Ear funnel, large, grey, Ø 4.0 mm, 10 x 100 pcs. in cartonKirchner & Wilhelm GmbH + Co KGFXG2023-08-30
00840183506872BR Surgical, LLCBR Surgical, LLCFXG2023-05-15
00840183510725BR Surgical, LLCBR Surgical, LLCFXG2023-05-15
54026704806305PILLINGTELEFLEX INCORPORATEDFXG2022-12-08
00842331151125Novo Surgical Inc. NOVO SURGICAL, INC.FXG2022-11-12
00887482116463Symmetry Surgical®SYMMETRY SURGICAL INC.FXG2022-09-29
07290018446126N9 speculumNONAGON LTDFXG2021-09-13
00812594011856Ocular Exam Kit NeonatalNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012488Neonatal Ocular Exam Kit 2-packNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012495Ocular Exam Kit StandardNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012501Ocular Exam DepressorNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012518Ocular Exam Neonatal SpeculumNEOTECH PRODUCTS, INC.FXG2021-06-14
00812594012525Ocular Exam Standard SpeculumNEOTECH PRODUCTS, INC.FXG2021-06-14
00190660180577Ambler SurgicalAMBLER SURGICAL CORP.FXG2021-01-04
04046964588761AESCULAPAESCULAP, INC.FXG2020-05-08
00845821004659BV MedicalBV MedicalFXG2018-09-24
00845821020833KaWeBV MedicalFXG2018-09-24
00845821020840KaWeBV MedicalFXG2018-09-24
00845821020857KaWeBV MedicalFXG2018-09-24
00845821020871KaWeBV MedicalFXG2018-09-24
00845821020888KaWeBV MedicalFXG2018-09-24