PRIME P3SAQF64

GUDID M684P3SAQF641

PRIME AM QUAD SHELL 64 MM GROUP F

Microport Orthopedics Inc.

Metallic acetabulum prosthesis

• Primary Device ID: M684P3SAQF641
• NIH Device Record Key: 75b124ff-f2b5-4257-9717-734e601ebfc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRIME
• Version Model Number: P3SAQF64
• Catalog Number: P3SAQF64
• Company DUNS: 079118736
• Company Name: Microport Orthopedics Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com
• Phone: +1(866)872-0211
• Email: Stephen.Weaver@ortho.microport.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192629283633 [Primary]
HIBCC	M684P3SAQF641 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202705

FDA Product Code

• OQG: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-10
• Device Publish Date: 2021-09-02

On-Brand Devices [PRIME]

• M684P3SAQG681: PRIME AM QUAD SHELL 68 MM GROUP G
• M684P3SAQG661: PRIME AM QUAD SHELL 66 MM GROUP G
• M684P3SAQF641: PRIME AM QUAD SHELL 64 MM GROUP F
• M684P3SAQF621: PRIME AM QUAD SHELL 62 MM GROUP F
• M684P3SAQE601: PRIME AM QUAD SHELL 60 MM GROUP E
• M684P3SAQE581: PRIME AM QUAD SHELL 58 MM GROUP E
• M684P3SAQD561: PRIME AM QUAD SHELL 56 MM GROUP D
• M684P3SAQD541: PRIME AM QUAD SHELL 54 MM GROUP D
• M684P3SAQC521: PRIME AM QUAD SHELL 52 MM GROUP C
• M684P3SAQC501: PRIME AM QUAD SHELL 50 MM GROUP C
• M684P3SAQB481: PRIME AM QUAD SHELL 48 MM GROUP B
• M684P3SAQB461: PRIME AM QUAD SHELL 46 MM GROUP B
• M684P3SAQA441: PRIME AM QUAD SHELL 44 MM GROUP A
• M684P3SAQA421: PRIME AM QUAD SHELL 42 MM GROUP A
• M684P3SBMG681: PRIME BIOFOAM MULTI-HOLE SHELL 68 MM GROUP G
• M684P3SBMG661: PRIME BIOFOAM MULTI-HOLE SHELL 66 MM GROUP G
• M684P3SBMF641: PRIME BIOFOAM MULTI-HOLE SHELL 64 MM GROUP F
• M684P3SBMF621: PRIME BIOFOAM MULTI-HOLE SHELL 62 MM GROUP F
• M684P3SBME601: PRIME BIOFOAM MULTI-HOLE SHELL 60 MM GROUP E
• M684P3SBME581: PRIME BIOFOAM MULTI-HOLE SHELL 58 MM GROUP E
• M684P3SBMD561: PRIME BIOFOAM MULTI-HOLE SHELL 56 MM GROUP D
• M684P3SBMD541: PRIME BIOFOAM MULTI-HOLE SHELL 54 MM GROUP D
• M684P3SBMC521: PRIME BIOFOAM MULTI-HOLE SHELL 52 MM GROUP C
• M684P3SBMC501: PRIME BIOFOAM MULTI-HOLE SHELL 50 MM GROUP C
• M684P3SBMB481: PRIME BIOFOAM MULTI-HOLE SHELL 48 MM GROUP B
• M684P3SBMB461: PRIME BIOFOAM MULTI-HOLE SHELL 46 MM GROUP B
• M684P3SBMA441: PRIME BIOFOAM MULTI-HOLE SHELL 44 MM GROUP A
• M684P3SBMA421: PRIME BIOFOAM MULTI-HOLE SHELL 42 MM GROUP A