Sterimed

GUDID 20867878000419

Band Bag 7" X 9" - 2 products/package (0284-2)

STERIMED LLC

X-ray system cover

• Primary Device ID: 20867878000419
• NIH Device Record Key: eb15483a-a8b6-4d7a-9daf-502398c2ecd3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterimed
• Version Model Number: 0284-2
• Company DUNS: 080284658
• Company Name: STERIMED LLC
• 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: true
• Lot Batch: true
• Serial Number: false
• 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: true

Customer Support Contacts

• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx
• Phone: 770-387-0771
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00867878000415 [Primary]
GS1	10867878000412 [Package]; Contains: 00867878000415; Package: Inner Pack/Box [100 Units]; In Commercial Distribution
GS1	20867878000419 [Package]; Contains: 10867878000412; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K853044

FDA Product Code

• IZI: System, X-Ray, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-09-18

On-Brand Devices [Sterimed]

• 10867878000498: Equipment Drape 18" X 24" (A4702) Non-sterile
• 00867878000484: Equipment Cover 36" X 92" W/Tape (3692)
• 00867878000477: Equipment Cover 40" X 65" W/Tape
• 20867878000464: Zeiss MD Microscope Drape, 40.5" x 56" (MG0056)
• 20867878000457: Microscope Drape 40.5" X 105" (ZO1000T)
• 10867878000443: 3 Piece Tray Cover Pack - 1 - 24” X 28” Clear, 1 - 24” X 28” Red, 1 - 34” X 30” Clea
• 20867878000433: Bag 5” X 14” (0514)
• 20867878000426: Handle Cover/Band Bag 5” X 12” (0384)
• 20867878000419: Band Bag 7" X 9" - 2 products/package (0284-2)
• 20867878000402: Handle Cover/Band Bag 7" X 9" (0284)
• 00850341007998: Band Bag 36" X 12" (0986B) Non-sterile
• 10850341007988: Band Bag 36" X 20" with tape tabs on corners (0120XB) Non-sterile
• 00850341007974: Probe Cover 5" X 12" (PC0512)
• 10850341007964: Band Bag 15" X 15" w/taped corners (A090) Non-sterile
• 10850341007957: Equipment Drape (Foot switch) 24" X 19" (A0307) Non-Sterile
• 10850341007940: Band Bag 30" X 30" Non-Sterile
• 10850341007933: Band Bag 36" X 28" Non-Sterile
• 10850341007926: Band Bag 36" X 30" Non-Sterile
• 10850341007919: Band Bag 20" X 15" (P/N A0889), Non-Sterile
• 20850341007909: Zeiss OPMI Microscope Drape 40.5" X 56"
• 10850341007896: Video Camera Cover with Blue Elastic Tip 10" X 18", Non-Sterile
• 20850341007886: 3 Piece Pack (1 - 44" X 25" Band Bag, 1 - 36" X 44" Drape, 1 - 40" X 65" Drape)
• 10850341007872: 3 Piece C-Arm Cover Pack (1 - 9" X 63" Drape, 2 - 36" X 25" Band Bags), Non-Sterile
• 20850341007862: 3 Piece C-Arm Cover Pack (1 - 9" X 63" Drape, 2 - 36" X 25" Band Bags)
• 20850341007855: 3 Piece C-Arm Cover Pack (1 - 9" X 70" Drape, 2 - 36" X 25" Band Bags)
• 20850341007848: Video Camera/Laser Arm Cover (Closed System) 7" X 96"
• 20850341007831: Video Camera/Laser Arm Cover with Clear Elastic Tip 7" X 96"
• 20850341007824: Video Camera/Laser Arm Cover with Blue Elastic Tip 7" X 96"
• 20850341007817: Zeiss Microscope Drape 40.5" X 105"
• 20850341007800: Microscope Drape (Laser Arm Attached) 40.5" X 120"
• 20850341007794: Zeiss Microscope Drape 20" X 96"
• 20850341007787: Equipment Drape 18" X 24" with Two Pieces of 1" Tape
• 10850341007773: Microscope Drape 53" X 105", Non-Sterile
• 20850341007763: Probe Cover 5" X 48"
• 20850341007756: Zeiss MD Microscope Drape 53" X 150"
• 20850341007749: C-Arm Cover with Extra Gathering Band 44" X 54"
• 10850341007735: Band Bag 44" X 40", Non-Sterile
• 10850341007728: Band Bag 44" X 40", Non-Sterile
• 10850341007711: Band Bag 44" X 25", Non-Sterile
• 10850341007704: Standard C-Arm Cover 36" X 54", Non-Sterile
• 10850341007698: Band Bag 28" X 12", Non-Sterile
• 10850341007681: Band Bag 28" X 18", Non-Sterile
• 10850341007674: Band Bag 36" X 25", Non-Sterile
• 10850341007667: Band Bag 36" X 41", Non-Sterile
• 10850341007650: Band Bag 36" X 36", Non-Sterile
• 10850341007643: Band Bag 36" X 30", Non-Sterile
• 10850341007636: Probe Cover 5" X 96", Non-sterile
• 10850341007629: C-Arm Cover with Straps 44" X 80", Non-sterile
• 10850341007612: Equipment Drape 36" X 44", Non-sterile
• 10850341007605: Cassette Cover 20" X 40 5/8", Non-sterile