HYDRACELL-ORTHO-5 HYDRA-ORTHO-5

GUDID 10850075308016

HYDRACELL-ORTHO-5 F/G, STERILE P/N 77134-01M

RANFAC CORP.

Bone access cannula

• Primary Device ID: 10850075308016
• NIH Device Record Key: 51670524-e92b-4c8a-b013-1f08bebd8325
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HYDRACELL-ORTHO-5
• Version Model Number: 11 Gauge x 6.1CM 5cc
• Catalog Number: HYDRA-ORTHO-5
• 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: true
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

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

Device Dimensions

• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter
• Needle Gauge: 11 Gauge
• Length: 6.1 Centimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850075308019 [Primary]
GS1	10850075308016 [Package]; Contains: 00850075308019; Package: CASE [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150563

FDA Product Code

• KNW: Instrument, Biopsy

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-03
• Device Publish Date: 2025-09-25

Devices Manufactured by RANFAC CORP.

• 10850075308016 - HYDRACELL-ORTHO-5: 2025-10-03HYDRACELL-ORTHO-5 F/G, STERILE P/N 77134-01M
• 10850075308016 - HYDRACELL-ORTHO-5: 2025-10-03 HYDRACELL-ORTHO-5 F/G, STERILE P/N 77134-01M
• 10850075308030 - HYDRACELL-ORTHO-10: 2025-10-03 HYDRACELL-ORTHO-10, F/G, STERILE P/N 77135-01M
• 10850075308047 - HYDRACELL-EXT-5: 2025-10-03 HYDRACELL-EXT-5 F/G, STERILE P/N 77136-01M
• 10850075308061 - HYDRACELL-EXT-10: 2025-10-03 HYDRACELL-EXT-10, F/G, STERILE P/N 77137-01M
• 10850075308115 - Cervos Platelet Separator Triple Pack B2: 2025-07-31 CER-PRP TRIPLE PACK B2 F/G, STERILE PN 76159-01M
• 00850075308002 - Ranfac Biopsy Needle, 11GA, 4": 2025-06-09 RBN-114SS, F/G, Sterile PN 74441-01M Customer # 0019886
• 10850075308023 - Cervos Platelet Separator Single 5 Pack: 2025-05-22 CER-PRP-SINGLE-5 F/G, STERILE PN 76158-01M
• 10850023741995 - CER-SUB-1590 CE: 2024-10-25 CER-SUB-1590, CE, F/G, STERILE, P/N 74439-01M