G7® Freedom® Vivacit-E®

Basic Information

• Brand Name: G7® Freedom® Vivacit-E®
• Primary DI: 00889024588554
• Version / Model: 30253202
• Catalog Number: 30253202
• Company Name: Zimmer, Inc.
• Labeler DUNS: 056038268
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-17
• Public Version: 1
• Public Version Date: 2022-05-25
• Public Version Status: New
• Public Device Record Key: 9c44457a-6eac-4599-8059-a464e3843517

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented	Orthopedic	888.3350	2
OQI	Hip, semi-constrained, cemented, metal/ceramic/polymer + additive, porous uncemented	Orthopedic	888.3353	2
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED	Orthopedic	888.3358	2
OQG	Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented	Orthopedic	888.3358	2
PBI	prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive	Orthopedic	888.3310	2
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer	Orthopedic	888.3310	2
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented	Orthopedic	888.3353	2
OQH	Hip, semi-constrained, cemented, metal/polymer + additive, cemented	Orthopedic	888.3350	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44362	Constrained polyethylene acetabular liner	A sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene) and may include a stabilizing component (e.g., a ring) to limit the range of motion of the hip to help prevent dislocation.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00889024588554	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K212512	000

Device Sizes

Type	Value	Unit	Text
Lumen/Inner Diameter	32.00	Millimeter
Device Size Text, specify			+5 mm Offset, Size B