RAN-1115 #0016008 74285-02M

GUDID 20858690006031

RAN-1115 Customer #0016008 PN 74285-02M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 20858690006031
• NIH Device Record Key: 58a801a2-7ef7-46b0-bfef-9ad3c1605ed6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RAN-1115 #0016008
• Version Model Number: 11 Gauge x 15 CM
• Catalog Number: 74285-02M
• Company DUNS: 121622872
• Company Name: RANFAC CORP.
• 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: 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

• Length: 15 Centimeter
• Length: 15 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00858690006037 [Primary]
GS1	10858690006034 [Package]; Contains: 00858690006037; Package: Inner Pack [1 Units]; In Commercial Distribution
GS1	20858690006031 [Package]; Contains: 10858690006034; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131157

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-05-09

Devices Manufactured by RANFAC CORP.

• 10850023741940 - MC-RAN-BZL-8C: 2024-04-12 MC-RAN-BZL-8C F/G, STERILE, P/N 74438-01M
• 10850023741919 - Cervos Platelet Separator Triple Pack ACDA: 2024-04-10 CER-PRP-TRIPLE-A F/G, STERILE PN: 76148-01M
• 10850023741902 - MC-RAN-BZL: 2024-03-27 MC-RAN-BZL F/G, STERILE, P/N 74436-01M
• 10850023741889 - Bone Marrow Biopsy Needle, RBN-114-BS: 2024-03-21 Bone Marrow Biopsy Needle, RBN-114-BS PN 74434-01M
• 10850023741865 - CER-BN-84-SCR: 2024-01-08 CER-BN-84-SCR, F/G, STERILE, P/N 74432-01M
• 00850023741875 - CER-SUB-1590: 2023-12-21 CER-SUB-1590, F/G, STERILE, P/N 74433-01M
• 10850023741803 - RAN-1528: 2023-11-28 NEEDLE, RAN-1528, F/G, STERILE, RANFAC P/N 74421-01M
• 10850023741810 - RBN-133: 2023-11-28 NEEDLE, RBN-133, F/G, STERILE, RANFAC P/N 74425-01M