FDA.reportPublic FDA data

Avalign

Primary DI
00190776072155
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM91-0111
Device description
Carter Sphere Introducer
Published
2021-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNPIntroducer, sphere

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNPIntroducer, SphereOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776072155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776072155001907760721551907760721550190776072155

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. 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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776404093Millennium85-670332562026-07-24
00190776404109Millennium85-670332512026-07-24
00190776404116Millennium85-670332762026-07-24
00190776404123Millennium85-670332662026-07-24
00190776404130Millennium85-670332712026-07-24
00190776404147Millennium85-200831492026-07-24
00190776404178Millennium85-520033262026-07-24
00190776404185Millennium85-510002082026-07-24
00190776404192Millennium85-750802482026-07-24
00190776404208Millennium85-200801322026-07-24
00190776404215Millennium85-200801372026-07-24
00190776404222Millennium85-420472272026-07-24
00190776404239Millennium85-140181602026-07-24
00190776405748Millennium85-428302392026-07-24
00190776405755Millennium2-74002026-07-24
00190776405762Millennium85-780694882026-07-24
00190776405779Millennium85-530180862026-07-24
00190776405786Millennium85-770111652026-07-24
00190776405793Millennium85-780703032026-07-24
00190776405809Millennium85-250081402026-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613011734MSI Precision Specialty InstrumentsMed Saver, Inc.HNP2025-03-21
00757770408320Bausch + LombBausch & Lomb IncorporatedHNP2024-11-20
00887482040010Symmetry FoxASPEN SURGICAL PRODUCTS, INC.HNP2024-08-20
00190776360276MillenniumAvalign Technologies, Inc.HNP2023-02-22
14026704802262PILLINGTELEFLEX INCORPORATEDHNP2022-12-08
54026704802260PILLINGTELEFLEX INCORPORATEDHNP2022-12-08
00842331166532Novo Surgical Inc. NOVO SURGICAL, INC.HNP2022-11-13
13760087126386SPHERE INTRODUCERFCI S A S FCI 20 22HNP2021-05-30
00190660109325Ambler SurgicalAMBLER SURGICAL CORP.HNP2021-01-07
00841668110836Sphere IntroducerKATENA PRODUCTS, INC.HNP2020-09-14
04046964686665AESCULAPAESCULAP, INC.HNP2020-08-25
03760087126389Orbital sphere implant introducerFCI S A S FCI 20 22HNP2020-02-26
00192896019317CARTER SPHERE INTRODUCERSONTEC INSTRUMENTS, INC.HNP2018-09-14
05060171621850Orbital Implant InserterCERAMISYS LTDHNP2015-07-31