Collimator Cradle 512 asm

GUDID 00884838081093

The collimator is intended for a larger compression height range with breasts of larger size.

Philips Digital Mammography Sweden AB

Fixed-aperture diagnostic x-ray system collimator

• Primary Device ID: 00884838081093
• NIH Device Record Key: e99ed7cb-189b-48be-81d7-5999e33237b5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Collimator Cradle 512 asm
• Version Model Number: 1024280
• Company DUNS: 632899233
• Company Name: Philips Digital Mammography Sweden AB
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838081093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130704

FDA Product Code

• IZW: Collimator, automatic, radiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-12
• Device Publish Date: 2016-09-19

Devices Manufactured by Philips Digital Mammography Sweden AB

• 00884838070943 - MicroDose SI: 2018-11-12 Philips MicroDose Mammography SI L50 is intended to produce radiographic images of the human breast for the purpose of diagnosti
• 00884838071001 - MicroDose SI: 2018-11-12 Philips MicroDose SI (Model: L50) is intended to produce radiographic images of the human breast for the purpose of diagnostic a
• 00884838081093 - Collimator Cradle 512 asm: 2018-11-12The collimator is intended for a larger compression height range with breasts of larger size.
• 00884838081093 - Collimator Cradle 512 asm: 2018-11-12 The collimator is intended for a larger compression height range with breasts of larger size.