Home GUDID 00190776395490 Millennium
Primary DI 00190776395490
Brand Millennium
Company Avalign Technologies, Inc.
Model 85-16051455
Device description Sims Rectal Speculum
Published 2026-07-14
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 Product Codes# Code, Name table Code Name FXE Speculum, Non-Illuminated
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class FXE Speculum, Non-Illuminated General, Plastic Surgery 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00190776395490 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00190776395490 00190776395490 190776395490 0190776395490
GMDN Terms# Term, Definition table Term Definition Hand-held surgical retractor, reusable A 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
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00810158218888 PRINCETON Princeton Medical Group, Inc. FXE 2026-02-16 00810158218895 PRINCETON Princeton Medical Group, Inc. FXE 2026-02-16 00810158218901 PRINCETON Princeton Medical Group, Inc. FXE 2026-02-16 00810158218178 PRINCETON Princeton Medical Group, Inc. FXE 2025-12-15 00810158218185 PRINCETON Princeton Medical Group, Inc. FXE 2025-12-15 00810158218192 PRINCETON Princeton Medical Group, Inc. FXE 2025-12-15 00194613065607 MSI Precision Specialty Instruments Med Saver, Inc. FXE 2025-08-01 00194613104726 MSI Precision Specialty Instruments Med Saver, Inc. FXE 2025-08-01 00194613120290 MSI Precision Specialty Instruments Med Saver, Inc. FXE 2025-08-01 00810158214699 PRINCETON Princeton Medical Group, Inc. FXE 2025-03-31 00810158214705 PRINCETON Princeton Medical Group, Inc. FXE 2025-03-31 00192896100671 TEALES GORGET SPECULUM SONTEC INSTRUMENTS, INC. FXE 2025-02-24 00190776390167 Millennium Avalign Technologies, Inc. FXE 2024-05-31 G586N6867570 Novo Surgical NOVO SURGICAL, INC. FXE 2023-12-18 G586N6867580 Novo Surgical NOVO SURGICAL, INC. FXE 2023-12-18 G586N6867590 Novo Surgical NOVO SURGICAL, INC. FXE 2023-12-18 G586N6867610 Novo Surgical NOVO SURGICAL, INC. FXE 2023-12-18 00190776041786 Avalign Avalign Technologies, Inc. FXE 2023-11-13 00192896115750 Teales Gorget Speculum SONTEC INSTRUMENTS, INC. FXE 2023-11-03 00190776316471 MILLENNIUM Avalign Technologies, Inc. FXE 2023-09-28 G453333611190 PEAK MEDICAL Peak Medical Distribution Inc. FXE 2023-09-12 G4533336204900 PEAK MEDICAL Peak Medical Distribution Inc. FXE 2023-09-12 00842962137956 HNM MEDICAL HNM STAINLESS, LLC. FXE 2023-04-02 00842962137963 HNM MEDICAL HNM STAINLESS, LLC. FXE 2023-04-02 00842962137970 HNM MEDICAL HNM STAINLESS, LLC. FXE 2023-04-02 00842962119150 HNM MEDICAL HNM STAINLESS, LLC. FXE 2023-03-30 14026704792211 PILLING TELEFLEX INCORPORATED FXE 2022-12-08 14026704792228 PILLING TELEFLEX INCORPORATED FXE 2022-12-08 54026704792219 PILLING TELEFLEX INCORPORATED FXE 2022-12-08 54026704792226 PILLING TELEFLEX INCORPORATED FXE 2022-12-08
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