ASPHERE 136555100

GUDID 10603295034001

ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +15.5 OFFSET

DEPUY (IRELAND)

Metallic femoral head prosthesis

• Primary Device ID: 10603295034001
• NIH Device Record Key: f412d984-636f-48ae-ae69-0801d23b243c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASPHERE
• Version Model Number: 1365-55-100
• Catalog Number: 136555100
• Company DUNS: 989365556
• Company Name: DEPUY (IRELAND)
• 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: false
• 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(800)255-2500
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	10603295034001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082585

FDA Product Code

• KWA: Prosthesis, hip, semi-constrained (metal uncemented acetabular component)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-03-24

On-Brand Devices [ASPHERE]

• 10603295034247: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 44mm +12 OFFSET
• 10603295034001: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +15.5 OFFSET
• 10603295033981: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +12 OFFSET
• 10603295033967: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +8.5 OFFSET
• 10603295033943: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +5 OFFSET
• 10603295033929: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm +1.5 OFFSET
• 10603295033905: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 36mm -2 OFFSET
• 10603295033806: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 40mm +6 OFFSET
• 10603295033783: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 40mm +3 OFFSET
• 10603295033769: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 40mm +0 OFFSET
• 10603295033554: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +12 OFFSET
• 10603295033530: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +9 OFFSET
• 10603295033516: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +6 OFFSET
• 10603295033394: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +3 OFFSET
• 10603295033370: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm +0 OFFSET
• 10603295033233: ASPHERE M-SPEC METAL FEMORAL HEAD 11/13 TAPER Diameter 36mm -3 OFFSET
• 10603295033011: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm +8.5 OFFSET
• 10603295032991: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm +5 OFFSET
• 10603295032977: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm +1.5 OFFSET
• 10603295032953: ASPHERE M-SPEC METAL FEMORAL HEAD 12/14 TAPER Diameter 40mm -2 OFFSET