FDA.reportPublic FDA data

Avalign

Primary DI
00190776043209
Brand
Avalign
Company
AVALIGN TECHNOLOGIES, INC.
Model
VM101-5682
Device description
House Bellucci Alligator Scissors
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
JZBSCISSORS, EAR

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776043209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776043209001907760432091907760432090190776043209

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
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
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
04250676746276Shea-Bellucci scissors, comfortSpiggle & Theis Medizintechnik GmbHJZB2025-09-08