FDA.reportPublic FDA data

MILLENNIUM

Primary DI
00190776378028
Brand
MILLENNIUM
Company
Avalign Technologies, Inc.
Model
85-16025868
Device description
Glassman Stomach Clamp
Published
2023-09-28
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
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776378028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776378028001907763780281907763780280190776378028

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
Premarket exempt
true
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
10849771050374NAKEY SURGICAL, INC.GDJ2023-03-31
G25003048090Backhaus Towel Forceps 9cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048110Backhaus Towel Forceps 11cmN S SURGICAL COMPANYGDJ2023-01-31
G25003048130Backhaus Towel Forceps 13cmN S SURGICAL COMPANYGDJ2023-01-31
10849771050381NAKEY SURGICAL, INC.GDJ2023-01-26
10849771050398NAKEY SURGICAL, INC.GDJ2023-01-26
14026704789570PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704789662PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704789679PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791160PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791177PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791184PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791191PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791276PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791283PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791290PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791306PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791566PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791573PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
14026704791634PILLINGTELEFLEX INCORPORATEDGDJ2022-12-08
10886982311146NASynthes GmbHGDJ2022-11-29
10886982311153NASynthes GmbHGDJ2022-11-29
10886982311160NASynthes GmbHGDJ2022-11-29
10886982311177NASynthes GmbHGDJ2022-11-29
ESOT001972NAS & T AGGDJ2022-09-15
ESOT001982NAS & T AGGDJ2022-09-15
ESOT002452NAS & T AGGDJ2022-09-15
ESOT002462NAS & T AGGDJ2022-09-15
ESOT002862NAS & T AGGDJ2022-09-15
ESOT002871NAS & T AGGDJ2022-09-15