FDA.report

Millennium

Primary DI
00190776385385
Brand
Millennium
Company
Avalign Technologies, Inc.
Model
1-PM5215
Device description
GILLIES SKIN HOOK, SHARP, MEDIUM, 7-1/2" (191MM), 2.9MM HOOK
Published
2024-08-29
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
GDGHook, Surgical, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GDGHook, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190776385385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190776385385001907763853851907763853850190776385385

GMDN Terms

TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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
00190776417901MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418335MillenniumAvalign Technologies, Inc.GDG2026-03-23
00190776418366MillenniumAvalign Technologies, Inc.GDG2026-03-23
04052536215522tezoUlrich GmbH & Co. KGGDG2026-03-16
00810158219328PRINCETONPrinceton Medical Group, Inc.GDG2026-03-12
00190776417826MillenniumAvalign Technologies, Inc.GDG2026-03-11
00190776417673MillenniumAvalign Technologies, Inc.GDG2026-03-04
00190776417512MillenniumAvalign Technologies, Inc.GDG2026-02-27
00190776416775MillenniumAvalign Technologies, Inc.GDG2026-02-20
00190776415761MillenniumAvalign Technologies, Inc.GDG2026-02-04
00190776415204MillenniumAvalign Technologies, Inc.GDG2026-01-27
00198506087431ELMED INCORPORATEDELMED INCORPORATEDGDG2026-01-07
03662663277082Timberline Lateral Fusion SystemHighridge Medical, LLCGDG2025-12-18
03662663277099Timberline Lateral Fusion SystemHighridge Medical, LLCGDG2025-12-18
03662663192798Breckenridge ACDF SystemHighridge Medical, LLCGDG2025-12-15
03662663192804Breckenridge ACDF SystemHighridge Medical, LLCGDG2025-12-15
00190776415129MillenniumAvalign Technologies, Inc.GDG2025-12-03
03662663131230Disc Preparation InstrumentsHighridge Medical, LLCGDG2025-12-03
03662663131247Disc Preparation InstrumentsHighridge Medical, LLCGDG2025-12-03
09348811019653INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-12-02
09348811108647INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-28
09348811155368INKAThe Trustee for KAISER FAMILY TRUSTGDG2025-11-28
00810207782605Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782612Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782629Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782636Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782643Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782650Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782667Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24
00810207782674Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDGDG2025-11-24