Huestis Medical Collimator

GUDID 00850077007132

150PBL/SC Collimator, ( Huestis Part # CM-3201-201 )

HUESTIS MACHINE CORPORATION

Automatic-aperture-control diagnostic x-ray system collimator

• Primary Device ID: 00850077007132
• NIH Device Record Key: 16956d3f-2c35-45ff-8eaa-85e04a1d2d94
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Huestis Medical Collimator
• Version Model Number: CM-3201-201
• Company DUNS: 001188390
• Company Name: HUESTIS MACHINE CORPORATION
• 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: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850077007132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972966

FDA Product Code

• IZX: Collimator, Manual, 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: 2018-07-06
• Device Publish Date: 2016-12-05

On-Brand Devices [Huestis Medical Collimator]

• 00850077007194: X-Ray Collimator, Huestis Part # CM-42015-001 PBL-RE/SC/IS/MSF QMI/GENERIC
• 00850077007156: 150M/XL AUX FL CABLE COLLIMATOR ( HUESTIS PART # CM-1020A-201)
• 00850077007149: 150PBL/SC Thin Mirror Collimator, ( Huestis Part # CM-3201-201 )
• 00850077007132: 150PBL/SC Collimator, ( Huestis Part # CM-3201-201 )
• 00850077007064: COVIDIEN PBL/HW/IS OEM Features, (Huestis Part# CM-32001-COV), (Liebel Part# 740925)
• 00850077007057: 150PBL-I Collimator, Iris Selectable, (Huestis Part# CM-3300B-002), (Liebel Part# 740920)
• 00850077007033: Collimator, Urology SCD, (Huestis Part # CM-1003), (GEHC part # 00-901620-01)
• 00850077007026: 6693-50FGE Automatic Collimator customized for GE with spectral filters, (Huestis Part# CM-32012
• 00850077007019: Collimator FRU for Definium 5000, (Huestis Part # CM-3201-008), (GEHC Part # 5212898), (GE # 66
• 00850077007002: X-Ray Collimator, Manual
• 00850077007279: 150PBL/SC Collimator (Huestis Part # CM-3201-102)
• 00850077007286: 150PBL Collimator (Huestis Part # CM-32211-QMI)