FDA.reportPublic FDA data

Avalign

Primary DI
00190776228200
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM106-0232
Device description
Laryngeal Knife,
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
JZYKNIFE, LARYNGEAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZYKnife, LaryngealEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776228200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776228200001907762282001907762282000190776228200

GMDN Terms#

Term, Definition table
TermDefinition
Laryngeal knifeA hand-held manual surgical instrument designed to cut and dissect laryngeal tissue, including the vocal cords, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and available in various shapes (e.g., sickle, flap, straight) according to the procedure performed (e.g., excision of cysts, adhesions, webs). 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
00190776228217AvalignAvalign Technologies, Inc.JZY2023-09-28
00190776328061MILLENNIUMAvalign Technologies, Inc.JZY2023-09-28
04055207039137NARichard Wolf GmbHJZY2022-08-09
04055207039144NARichard Wolf GmbHJZY2022-08-09
04055207039151NARichard Wolf GmbHJZY2022-08-09
04055207039168NARichard Wolf GmbHJZY2022-08-09
00190776050191AvalignAVALIGN TECHNOLOGIES, INC.JZY2021-11-03
00190660093402Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
00190660093419Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
00190660093426Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
00190660093433Ambler SurgicalAMBLER SURGICAL CORP.JZY2021-01-07
04046826136338MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
04046826136369MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
04046826136376MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
04046826136345MediconMedicon eG. Chirurgiemechaniker-GenossenschaftJZY2020-09-24
M6334281900JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282120JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M63342821210JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282140JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282160JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282180JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
M6334282200JEDMEDJEDMED INSTRUMENT COMPANYJZY2020-09-01
04038653180622AESCULAPAesculap AGJZY2020-06-17
04038653053964AESCULAPAesculap AGJZY2020-04-20
10381780090984Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-26
10381780086246Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780086260Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780086291Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780086307Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-10-24
10381780074946Integra®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONJZY2018-09-17