FDA.reportPublic FDA data

Millennium

Primary DI
00190776381851
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
72-525671
Device description
LBC 50-P Bipolar Coagulator with ARFM Coagulation Monitor + Digital Wattage Display
Published
2023-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HINCoagulator-Cutter, Endoscopic, Bipolar (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776381851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776381851001907763818511907763818510190776381851

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorAn electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190776408534Millennium72-9819S2025-08-19
00190776406769MillenniumM1571842025-07-24
00190776392789Millennium72-9820PA2025-05-05
00190776384715Millennium72-402229IL2024-08-22
00190776383084Millennium72-9820PP2024-07-24
00190776300524Millennium72-5298200102023-11-15
00190776300531Millennium72-61948002023-11-15
00190776301576Millennium72-4262822023-11-15
00190776301750Millennium72-9820OLY2023-11-15
00190776374846Millennium72-98842023-09-08
00190776375515MillenniumM1570572023-09-08
00190776378592MillenniumM133562023-09-08
00190776294830Millennium72-5062642022-12-12
00190776189396Millennium72-58192021-11-02
00190776189501MillenniumFTIMG105802021-11-02
00190776205485Millennium72-3612061B2021-11-02
00190776157296MillenniumMFOCAAF375GA2021-01-22
00190776421311Millennium72-4286052026-05-05
00190776421328Millennium1-3552062026-05-05
00190776421335Millennium1-S50177512026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089381ELMED INCORPORATEDELMED INCORPORATEDHIN2026-04-02
05708265016389LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
05708265016402LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
05708265016426LiNA Bipolar Loop™LiNA Medical AGHIN2026-04-02
B382SD80055210Surgical DirectSurgical Direct, Inc.HIN2026-02-12
00842180135437ELMED INCORPORATEDELMED INCORPORATEDHIN2025-09-29
00842180135475ELMED INCORPORATEDELMED INCORPORATEDHIN2025-09-29
00198506026027ELMED INCORPORATEDELMED INCORPORATEDHIN2025-05-22
00198506026034ELMED INCORPORATEDELMED INCORPORATEDHIN2025-03-11
00198506020841ELMED INCORPORATEDELMED INCORPORATEDHIN2025-03-05
06976860690375ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690382ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690399ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
06976860690405ClearVisionOriGyn Medical Technology (Hangzhou) Co., Ltd.HIN2024-09-23
00887482128596Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HIN2024-09-09
00887482128602Symmetry SurgicalASPEN SURGICAL PRODUCTS, INC.HIN2024-09-09
00198506060731ELMED INCORPORATEDELMED INCORPORATEDHIN2024-08-26
00190776126421MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776126438MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127121MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127152MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127190MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127626MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776127817MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776131661MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776142476MillenniumAvalign Technologies, Inc.HIN2023-11-14
00190776376093MillenniumAvalign Technologies, Inc.HIN2023-09-08
00190776376109MillenniumAvalign Technologies, Inc.HIN2023-09-08
00190776377250MillenniumAvalign Technologies, Inc.HIN2023-09-08
00842180172012ELMEDELMED INCORPORATEDHIN2023-06-20