FDA.reportPublic FDA data

Millennium

Primary DI
00190776296063
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-510822CH
Device description
Retractable Needle
Published
2022-12-12
Public version status
Update
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
NWWHysteroscope accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWWHysteroscope AccessoriesObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776296063PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776296063001907762960631907762960630190776296063

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, reusableA sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. 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
00190776416379MillenniumAvalign Technologies, Inc.NWW2026-02-16
10850033976356HERizon Disposable Endoscopic Scissors XLMinerva Surgical, Inc.NWW2026-02-13
00198506087943ELMED INCORPORATEDELMED INCORPORATEDNWW2026-01-16
00190776410872MillenniumAvalign Technologies, Inc.NWW2025-09-15
00190776410544MillenniumAvalign Technologies, Inc.NWW2025-09-11
06976860690412OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690429OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690436OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690443OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690450OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690467OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690474OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690481OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690498OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
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06976860690535OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690542OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690559OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690566OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690573OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690580OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690597OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690603OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690610OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690627OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690634OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690641OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28
06976860690658OriGynMEDOriGyn Medical Technology (Hangzhou) Co., Ltd.NWW2025-08-28