FDA.reportPublic FDA data

Avalign

Primary DI
00190776044718
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM101-5516
Device description
House Gelfoam Press,
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
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776044718PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776044718001907760447181907760447180190776044718

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue manipulation forceps, probe-like, single-useA sterile, hand-held manual instrument designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It has a probe-like design with a proximal handle (typically cylindrical), a thin cannula-like shaft, and small grasping blades that protrude from the distal end of the shaft. This is a single-use 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
00198506090967ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-26
00198506090974ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-26
00198506090981ELMED INCORPORATEDELMED INCORPORATEDLRC2026-05-26
00190776417970MillenniumAvalign Technologies, Inc.LRC2026-03-23
00198506089756ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-23
00198506089657ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-17
00198506089534ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089541ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089558ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
00198506089572ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-13
08904461031073OSSEOUS-Ear/Nasal ExtractorEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
08904428798377OSSEOUS-CapsuleEON MEDITECH PRIVATE LIMITEDLRC2026-03-13
00198506088926ELMED INCORPORATEDELMED INCORPORATEDLRC2026-03-03
00190776417420MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417475MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417482MillenniumAvalign Technologies, Inc.LRC2026-02-27
00190776417543MillenniumAvalign Technologies, Inc.LRC2026-02-27
00198506088865ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-25
00198506088469ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00198506088544ELMED INCORPORATEDELMED INCORPORATEDLRC2026-02-23
00190776416546MillenniumAvalign Technologies, Inc.LRC2026-02-16
00190776415914MillenniumAvalign Technologies, Inc.LRC2026-02-06
00190776415778MillenniumAvalign Technologies, Inc.LRC2026-02-04
04059453133779Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-02-02
00198506088346ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-30
04059453133755Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRC2026-01-29
09348811102638INKAThe Trustee for KAISER FAMILY TRUSTLRC2026-01-28
00190776415495MillenniumAvalign Technologies, Inc.LRC2026-01-27
00198506088070ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-23
00198506087813ELMED INCORPORATEDELMED INCORPORATEDLRC2026-01-16