Polaroid DDS PDDS

GUDID 00667147001545

Polaroid DDS software

Synca Marketing Inc

Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software Radiology information system application software

• Primary Device ID: 00667147001545
• NIH Device Record Key: 8d123377-d263-41f6-9bba-ed506d1ebae8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Polaroid DDS
• Version Model Number: V8
• Catalog Number: PDDS
• Company DUNS: 247111768
• Company Name: Synca Marketing 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00667147001545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062237

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-07-23
• Device Publish Date: 2021-07-15

Devices Manufactured by Synca Marketing Inc

• 00667147100088 - FIBER FORCE: 2021-08-03 PINK BRAIDED ROPE 1MM (2-150MM)
• 00667147100095 - FIBER FORCE: 2021-08-03 PINK BRAIDED ROPE 2MM (2-150MM)
• 00667147100101 - FIBER FORCE: 2021-08-03 PINK MESH (2-53MMx80MM)
• 00667147100118 - FIBER FORCE: 2021-08-03 WHITE BRAIDED ROPE 2MM ( 2-150MM)
• 00667147100125 - FIBER FORCE: 2021-08-03 PINK UD FIBERS (2-150MM)
• 00667147100187 - FAST SPLINT MATRIX: 2021-08-03 COMPRESSIBLE HYBRID FIBERS 1:1 (5-55MM)
• 00667147100194 - FAST SPLINT MATRIX: 2021-08-03 COMPRESSIBLE HYBRID FIBERS 1:4 (5-55MM)
• 00667147100200 - FAST SPLINT MATRIX: 2021-08-03 ADHESIVE WAX STRIPS FOR 1:4 FIBERS (8-55MM)