COMPRESSION PADDLE

GUDID 00843696114312

Designed for applying compression during G.I. series, our Wolf Compression Paddle is ideal for displacing barium, deflecting an intestinal loop, or applying compression for similar reasons. The Paddle features a rubber compression bladder, easily inflated by means of a built-in Baumanometer bulb. A metal circle in the bladder ring fluoroscopically indicates the area under compression.

Flow X Ray Corporation

Mammographic x-ray system compression paddle

• Primary Device ID: 00843696114312
• NIH Device Record Key: cb9f594d-4711-4707-b943-80cf233c9e62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMPRESSION PADDLE
• Version Model Number: 14107
• Company DUNS: 010016319
• Company Name: Flow X Ray Corporation
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: false
• 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	00843696114312 [Primary]

FDA Product Code

• HWN: Instrument, Compression

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-28
• Device Publish Date: 2022-12-22

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• 00812045030832 - DV-57 ADULT TWIN VALUE PAK: 2023-08-17 D Speed, Size 2, 130 Double Film Packets.
• 00812045030849 - DV-53 CHILD TWIN PEDO PAK: 2023-08-17 D Speed, Size 0, 100 Double Film Packets.
• 00812045030856 - DSS-54 D CHILD SINGLE FILM BUTTERFLY PACKET: 2023-08-17 D Speed, Size 0, 75 Single Film Butterfly Barrier Packets
• 00812045030863 - DSS-57 D ADULT SINGLE FILM BUTTERFLY PACKET: 2023-08-17 D Speed, Size 2, 100 Single Film Butterfly Barrier Packets.
• 00812045030870 - DUPLICATING FILM, 14 X 17": 2023-08-17 Duplicating Film, 14x17", 100 sheets per box.