MANZA POLYETHYLENE LINER 102-10-033

GUDID 00841176101128

MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 E

STINSON ORTHOPEDICS INC.

Non-constrained polyethylene acetabular liner

• Primary Device ID: 00841176101128
• NIH Device Record Key: 634dbea7-c4c0-41ea-a5ef-f15ba562bd00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANZA POLYETHYLENE LINER
• Version Model Number: 102-10-033
• Catalog Number: 102-10-033
• Company DUNS: 080460688
• Company Name: STINSON ORTHOPEDICS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841176101128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121297

FDA Product Code

• MEH: Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Non-Porous, Calicum-Phosphate

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-26

On-Brand Devices [MANZA POLYETHYLENE LINER]

• 00841176101333: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 40 E 10 DEGREE
• 00841176101326: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 40 E
• 00841176101319: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 40 D
• 00841176101159: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 36 E
• 00841176101142: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 36 D
• 00841176101135: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 36 C
• 00841176101128: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 E
• 00841176101111: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 D
• 00841176101104: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 C
• 00841176101098: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 32 B
• 00841176101081: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 28 C
• 00841176101074: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 28 B
• 00841176101067: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED HOODED 28 A
• 00841176101043: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 40 E
• 00841176101036: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 40 D
• 00841176101029: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 36 E
• 00841176101012: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 36 D
• 00841176101005: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 36 C
• 00841176100992: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 32 E
• 00841176100985: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 32 D
• 00841176100978: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 32 C
• 00841176100961: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 32 B
• 00841176100954: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 28 C
• 00841176100947: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 28 B
• 00841176100930: MANZA HIGH CROSS LINKED AND ANNEALED POLY LINER LATERALIZED NEUTRAL 28 A
• 00841176100916: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 40 D 10 DEGREE
• 00841176100909: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 36 E 10 DEGREE
• 00841176100893: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 36 D 10 DEGREE
• 00841176100886: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 32 E 10 DEGREE
• 00841176100879: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 32 D 10 DEGREE
• 00841176100862: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 32 C 10 DEGREE
• 00841176100855: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 32 B 10 DEGREE
• 00841176100848: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 28 C 10 DEGREE
• 00841176100831: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 28 B 10 DEGREE
• 00841176100824: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 28 A 10 DEGREE
• 00841176100817: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 40 E
• 00841176100800: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 40 D
• 00841176100794: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 36 E
• 00841176100787: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 36 D
• 00841176100770: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 36 C
• 00841176100763: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 32 E
• 00841176100756: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 32 D
• 00841176100749: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 32 C
• 00841176100732: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 32 B
• 00841176100725: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 28 C
• 00841176100718: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 28 B
• 00841176100701: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER NEUTRAL 28 A
• 00841176100695: MANZA HIGH CROSS LINKED AND ANNEALED POLYETHYLENE LINER 36 C 10 DEGREE