FDA.report

Millennium

Primary DI
00190776353056
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
12-205117
Device description
LeRoy Scalp Clip Applying Forcep
Published
2023-11-17
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
GDOApplier, surgical, clip

Product Code Classifications

CodeDeviceSpecialtyClass
GDOApplier, Surgical, ClipGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776353056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776353056001907763530561907763530560190776353056

GMDN Terms

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
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
24026704921335WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921342WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921359WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921366WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921373WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921380WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921403WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921410WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921427WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921434WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921441WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921458WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921571WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921588WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921595WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921618WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921625WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921632WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921663WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921670WECKTELEFLEX INCORPORATEDGDO2026-03-10
24026704921687WECKTELEFLEX INCORPORATEDGDO2026-03-10
B382SD5715300Surgical DirectSurgical Direct, Inc.GDO2026-03-09
B382SD87531140Surgical DirectSurgical Direct, Inc.GDO2026-03-09
B382SD32155560Surgical DirectSurgical Direct, Inc.GDO2026-02-26
B382SD32155520Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155530Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155540Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32155550Surgical DirectSurgical Direct, Inc.GDO2026-02-25
B382SD32152540Surgical DirectSurgical Direct, Inc.GDO2026-02-20
14026704935496WECKTELEFLEX INCORPORATEDGDO2026-02-06