Aligned Medical Solutions AMS15047A

GUDID B098AMS15047A1

TOTAL HIP PACK

Aligned Medical Solutions

Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: B098AMS15047A1
• NIH Device Record Key: aea32e68-ad39-4f11-8d1a-6da7ef0f2d42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aligned Medical Solutions
• Version Model Number: AMS15047A
• Catalog Number: AMS15047A
• Company DUNS: 106580145
• Company Name: Aligned Medical Solutions
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 8006377056
• Email: CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM
• Phone: 8006377056
• Email: CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM
• Phone: 8006377056
• Email: CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM
• Phone: 8006377056
• Email: CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM
• Phone: 8006377056
• Email: CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM
• Phone: 8006377056
• Email: CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM
• Phone: 8006377056
• Email: CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM
• Phone: 8006377056
• Email: CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM
• Phone: 8006377056
• Email: CUSTOMERSERVICE@ALIGNEDMEDICALSOLUTIONS.COM

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B098AMS15047A0 [Primary]
HIBCC	B098AMS15047A1 [Package]; Contains: B098AMS15047A0; Package: CASE [4 Units]; In Commercial Distribution

FDA Product Code

• OJH: Orthopedic Tray

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: 2024-11-20
• Device Publish Date: 2024-11-12

On-Brand Devices [Aligned Medical Solutions]

• B09800109121: Goller ER Tray-RX
• B09800107411: Port Tray - RX
• B098001072101: Large Pack
• B09800107171: Face Pack
• B09800106821: SAVI Procedure Kit
• B09800104551: Shoulder Arthroscopy Pack
• B09800103101: Mosquito Curved Forcep
• B09800101361: Knee Arthroscopy Pack
• B098AMSSSKIT1: Shoulder Suspension System Kit
• B098AMS6619A1: Podiatry Pack
• B098AMS66101: Cysto Pack
• B098AMS66091: Vasectomy Pack
• B098AMS6606B1: Pain Management Tray
• B098AMS6606A1: Pain Management Tray
• B098AMS6605A1: Shoulder Arthro Pack
• B098AMS6604A1: Cysto/U-Scope Pack
• B098AMS6603A1: Open Shoulder Pack
• B098AMS6602A1: Lower Extremity Pack
• B098AMS6601B1: Knee Arthro Video Pack
• B098AMS6600A1: General Laparoscopic Pack
• B098AMS6599B1: Hand Pack
• B098AMS65991: Hand Pack
• B098AMS6598A1: Head and Neck Pack
• B098AMS65971: Minor Pack
• B098AMS65961: VCA Smoketown Pack
• B098AMS65881: Arthroscopy Pack
• B098AMS65871: Hand Pack
• B098AMS65851: Extremity Pack
• B098AMS6584A1: Laparotomy Pack
• B098AMS6583B1: Shoulder Pack
• B098AMS6582A1: Knee Pack
• B098AMS65731: Bone Marrow Pack (11862)
• B098AMS6572A1: Breast Biopsy Pack (24771)
• B098AMS65721: Breast Biopsy Pack (24771)
• B098AMS6571A1: Angio Pack (22750)
• B098AMS65711: Angio Pack (22750)
• B098AMS6570A1: Minor Procedure Pack (20527)
• B098AMS65691: Ports Cath Pack (1794)
• B098AMS6568A1: Cysto Pack (1343)
• B098AMS65681: Cysto Pack (1343)
• B098AMS6567B1: Lap Chole Pack (6037)
• B098AMS6566B1: Lap Minor Pack (1346)
• B098AMS6566A1: Lap Minor Pack (1346)
• B098AMS6565B1: Major Pack (1345)
• B098AMS6564B1: Hip Pack (1347)
• B098AMS6563B1: Total Knee Pack (15710)
• B098AMS6562B1: Laparoscopy Pack (1184)
• B098AMS6561B1: Extremity Pack (1344)
• B098AMS6560A1: Basic Pack (1185)
• B098AMS6559B1: Arthroscopy Pack (1181)