NDL, RBN-132 RBN-132

GUDID M9797405005M9

NDL, RBN-132, STERILE, F/G

RANFAC CORP.

Bone marrow biopsy needle, single-use

• Primary Device ID: M9797405005M9
• NIH Device Record Key: 735226f4-c0c9-4b8b-896c-7fbb32dd979e
• Commercial Distribution Discontinuation: 2025-11-20
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: NDL, RBN-132
• Version Model Number: 13 GAUGE x 2"
• Catalog Number: RBN-132
• 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
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com
• Phone: 5085884400
• Email: info@ranfac.com

Device Dimensions

• Needle Gauge: 13 Gauge
• Length: 2 Inch
• Needle Gauge: 13 Gauge
• Length: 2 Inch
• Needle Gauge: 13 Gauge
• Length: 2 Inch
• Needle Gauge: 13 Gauge
• Length: 2 Inch
• Needle Gauge: 13 Gauge
• Length: 2 Inch
• Needle Gauge: 13 Gauge
• Length: 2 Inch

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M9797405005M0 [Primary]
HIBCC	M9797405005M1 [Package]; Contains: M9797405005M0; Package: Inner Pack [10 Units]; Discontinued: 2025-11-20; Not in Commercial Distribution
HIBCC	M9797405005M9 [Package]; Contains: M9797405005M1; Package: Case [12 Units]; Discontinued: 2025-11-20; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983187

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: 4
• Public Version Date: 2025-11-21
• Device Publish Date: 2017-05-08

Devices Manufactured by RANFAC CORP.

• M9797405001M9 - NDL, RBN-114, STERILE, F/G: 2025-11-21 NDL, RBN-114, STERILE, F/G PN 74050-01M
• M9797405003M9 - NDL, RBN-133, STERILE, F/G: 2025-11-21 NDL, RBN-133, STERILE, F/G PN 74050-03M
• M9797405005M9 - NDL, RBN-132: 2025-11-21NDL, RBN-132, STERILE, F/G
• M9797405005M9 - NDL, RBN-132: 2025-11-21 NDL, RBN-132, STERILE, F/G
• 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