FDA.report

Millennium

Primary DI
00190776198220
Brand
Millennium
Company
AVALIGN TECHNOLOGIES, INC.
Model
72-230056
Device description
Bergstrom SMBN Skel Muscle Biop
Published
2021-11-02
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
GEEBRUSH, BIOPSY, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GEEBrush, Biopsy, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776198220PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776198220001907761982201907761982200190776198220

GMDN Terms

TermDefinition
Surgical instrument/endoscope cleaning brush/tool, reusableA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. 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
00860011506348SWAB-PAKMedical Packaging CorporationGEE2026-02-18
00860011506355SWAB-PAKMedical Packaging CorporationGEE2026-02-18
00816207021720Biopsy BrushENDO-THERAPEUTICS, INC.GEE2025-02-26
16971317521766StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
16971317521773StatLabYancheng Huida Medical Instruments Co., Ltd.GEE2024-05-01
00190776300708MillenniumAvalign Technologies, Inc.GEE2023-11-15
00190776301637MillenniumAvalign Technologies, Inc.GEE2023-11-15
00190776198176MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198183MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198190MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198206MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198213MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198237MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198244MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198251MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198268MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198275MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198282MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198299MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198305MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
00190776198312MillenniumAVALIGN TECHNOLOGIES, INC.GEE2021-11-02
10653405051046CONMEDConmed CorporationGEE2021-10-05
10653405051053CONMEDConmed CorporationGEE2021-10-05
00840314247988gSourceGSOURCE LLCGEE2020-11-02
00840314247995gSourceGSOURCE LLCGEE2020-11-02
M7559901020gSourceGSOURCE LLCGEE2020-11-02
00763000374839Midas RexMEDTRONIC POWERED SURGICAL SOLUTIONSGEE2020-10-02
00763000374853Midas RexMEDTRONIC POWERED SURGICAL SOLUTIONSGEE2020-10-02
00763000374877Midas RexMEDTRONIC POWERED SURGICAL SOLUTIONSGEE2020-10-02
M7559901000gSourceGSOURCE LLCGEE2020-09-25