FDA.reportPublic FDA data

Millennium

Primary DI
00190776435899
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
85-P605-22
Device description
Suture/Catheter Organizer
Published
2026-09-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190776435899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776435899001907764358991907764358990190776435899

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument interim-placement holder, reusableA device intended to be used in the operating room (OR) by staff to safely hold a manual, surgical instrument(s) [e.g., needle, scalpel, scissors] when not in use during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
18772891096product.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
00190776433017Millennium1-3201222026-10-01
00190776433024Millennium1-5255712026-10-01
00190776433031Millennium72-52832404M2026-10-01
00190776433048Millennium1-3201042026-10-01
00190776433055Millennium1-7752SD2026-10-01
00190776433062Millennium72-31940512026-10-01
00190776433079Millennium72-317910012026-10-01
00190776433086Millennium72-180526NR2026-10-01
00190776433093Millennium72-4220812026-10-01
00190776433109Millennium1-3202132026-10-01
00190776433116Millennium1-2051362026-10-01
00190776433123Millennium72-23011WS2026-10-01
00190776433130Millennium72-2411004CM2026-10-01
00190776433147Millennium72-2411003CM2026-10-01
00190776433154Millennium72-5242002H2026-10-01
00190776433161Millennium72-5242003H2026-10-01
00190776433178Millennium72-2414002026-10-01
00190776433185Millennium92-H0498R2026-10-01
00190776432911Millennium72-2430130452026-09-30
00190776432928Millennium72-5225522B42026-09-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776434595MillenniumAvalign Technologies, Inc.FSM2026-09-30
16931918122397AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918176680AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918191614AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
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