FDA.report

Millennium

Primary DI
00190776354749
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
27-016373
Device description
Landolt Scalpel Handle
Published
2023-11-17
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

Related Records

Contact Domains

Product Codes

CodeName
GZXINSTRUMENT, MICROSURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776354749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776354749001907763547491907763547490190776354749

GMDN Terms

TermDefinition
Ear knifeA hand-held manual surgical instrument intended to cut and dissect tissues of the ear during a surgical intervention. It is typically designed as a one-piece instrument with a sharp, single-edged, cutting blade at the distal end; this is normally quite small and may be of various shapes, and has a long slender shaft with a handle at the proximal end. It is normally made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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 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 DIBrandCompanyProduct codePublished
04058749002157NAFehling Instruments GmbH & Co. KGGZX2026-01-28
00192896122130Avian Set With TraySONTEC INSTRUMENTS, INC.GZX2025-09-26
04058749013801NAFehling Instruments GmbH & Co. KGGZX2025-08-29
00194613077624MSI Precision Specialty InstrumentsMed Saver, Inc.GZX2025-08-01
00194613077631MSI Precision Specialty InstrumentsMed Saver, Inc.GZX2025-08-01
00194613077648MSI Precision Specialty InstrumentsMed Saver, Inc.GZX2025-08-01
00888118145901SCISSORSKLS-Martin L.P.GZX2025-05-26
00888118145918SCISSORSKLS-Martin L.P.GZX2025-05-26
00888118146007DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146014DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146021DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146038DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146045DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146052DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146069DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146076DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146083DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146090DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146106DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146113DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146120DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146137DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146144DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146151DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146168DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146175DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146182DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146199DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146205DISSECTORKLS-Martin L.P.GZX2025-05-26
00888118146212DISSECTORKLS-Martin L.P.GZX2025-05-26