ORC TYPE XL-11 XL-11

GUDID 20858690006321

LAPAROSCOPIC CHOLANGIOGRAPHY CTHTR-11 ORC TYPE XL-11 PN 68012-01M

RANFAC CORP.

Rigid endoscopic cannula, single-use

• Primary Device ID: 20858690006321
• NIH Device Record Key: b61c32b2-55f1-445e-8b49-224a92ce920d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORC TYPE XL-11
• Version Model Number: 18 GA x 11"
• Catalog Number: XL-11
• Company DUNS: 121622872
• Company Name: RANFAC CORP.
• Device Count: 1
• DM Exempt: false
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 5085884400
• Email: info@ranfac.com

Device Dimensions

• Needle Gauge: 18 Gauge
• Needle Gauge: 18 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858690006327 [Primary]
GS1	10858690006324 [Package]; Contains: 00858690006327; Package: Inner Pack [10 Units]; In Commercial Distribution
GS1	20858690006321 [Package]; Contains: 10858690006324; Package: Case [6 Units]; In Commercial Distribution

FDA Product Code

• GBZ: Catheter, Cholangiography

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: 2017-05-04

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