FDA.reportPublic FDA data

Millennium

Primary DI
00190776435240
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-9865IS
Device description
Tebbetts Fiberoptic Rt. Angle Retractor Light 9cm 30mm without teeth
Published
2026-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FDGRetractor, Fiberoptic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDGRetractor, FiberopticGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776435240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776435240001907764352401907764352400190776435240

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
00190776435219Millennium63-G12015NE2026-10-19
00190776435226Millennium1-3204302026-10-19
00190776435233Millennium63-G53012026-10-19
00190776435257Millennium1-242207C2026-10-19
00190776435264Millennium1-0101672026-10-19
00190776435271Millennium1-0201862026-10-19
00190776435288Millennium72-5223612B12026-10-19
00190776435295Millennium72-52536462026-10-19
00190776435301Millennium63-36303SP-BL2026-10-19
00190776435318Millennium92-F31012026-10-19
00190776435325Millennium1-013L2026-10-19
00190776435332Millennium1-007L2026-10-19
00190776435349Millennium1-110570-92026-10-19
00190776435356Millennium1-26582026-10-19
00190776435363Millennium1-21585-72026-10-19
00190776435370Millennium1-3602742026-10-19
00190776435387Millennium1-3602752026-10-19
00190776435394Millennium1-BIO110432026-10-19
00190776435400Millennium1-1002912026-10-19
00190776435417Millennium72-4270132026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G141572101010Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210110Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210310Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210630Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210690Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210870Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G14157210920Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-10-07
G1415543110400Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157204210Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210130Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210200Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572103590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210570Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210590Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210670Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G141572107270Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
G14157210830Carnegie Surgical LLCCarnegie Surgical LLCFDG2026-09-30
00840329838867N/ABLACK & BLACK SURGICAL, INC.FDG2026-09-29
G425110676LSI0My MedicalMy Medical Store LLCFDG2026-05-04
G425110686LSI0My MedicalMy Medical Store LLCFDG2026-05-04
00812432023140Medtronic Surgical Illuminator - TubeLumitex, Inc.FDG2026-04-17
00812432023157Medtronic Surgical Illuminator - BladeLumitex, Inc.FDG2026-04-17
00812432023218Lumitex Surgical Tube IlluminatorLumitex, Inc.FDG2026-03-23
G4255721131S0My MedicalMy Medical Store LLCFDG2026-02-27
00812432023133Light Cable, Vaginal RetractorLumitex, Inc.FDG2026-02-11
00812432021559Lumitex MD 3.75mm ACMI Reusable Light CableLumitex, Inc.FDG2026-01-29
00812432023164Medtronic 4mm Universal Reusable Light CableLumitex, Inc.FDG2026-01-07
00812432023171Medtronic 4mm ACMI Cable AdapterLumitex, Inc.FDG2026-01-07
00812432023188Medtronic 4mm WOLF Cable AdapterLumitex, Inc.FDG2026-01-07
00812432023195Medtronic 4mm OLYMPUS Cable AdapterLumitex, Inc.FDG2026-01-07