FDA.reportPublic FDA data

Avalign

Primary DI
00190776034351
Brand
Avalign
Company
Avalign Technologies, Inc.
Model
VM101-5696
Device description
Ear Scissors, Straight
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
JZBSCISSORS, EAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZBScissors, EarEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776034351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776034351001907760343511907760343510190776034351

GMDN Terms#

Term, Definition table
TermDefinition
Ear scissors, reusableA long, thin, hand-held manual surgical instrument designed to cut tissue during ear surgery; it is not intended for insertion through an endoscope. Sometimes referred to as alligator scissors, it typically has a slender body (to allow for restricted access) and small shearing blades which are hinged at the distal (working) end. It is made of metal and available in various sizes/lengths; the blades may have carbide inserts along the cutting edges. 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
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811114891INKAThe Trustee for KAISER FAMILY TRUSTJZB2026-04-24
09348811114808INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-03
09348811114839INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-01
09348811114976INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-12-01
09348811114815INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811114822INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811114853INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811114860INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811115003INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811115041INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811172129INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-26
09348811115027INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-25
09348811172136INKAThe Trustee for KAISER FAMILY TRUSTJZB2025-11-25
04250381854136Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250381854143Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250381854150Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676731920Reference instrumentSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676745682ScissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676745705ScissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-25
04250676745736ScissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-24
04250381854105Shea-Bellucci ear scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676708915Scissors model BonnSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676744913Stapes scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676744920Stapes scissorsSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746207Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746214Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746221Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746238Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746245Shea-Bellucci ear scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08
04250676746269Shea-Bellucci scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08