NDL, RBN-133, STERILE, F/G RBN-133

GUDID M9797405003M9

NDL, RBN-133, STERILE, F/G PN 74050-03M

RANFAC CORP.

Bone marrow biopsy needle, single-use
Primary Device IDM9797405003M9
NIH Device Record Key8d778e1b-6736-4cab-8875-f2a4ae01da43
Commercial Distribution Discontinuation2025-11-20
Commercial Distribution StatusNot in Commercial Distribution
Brand NameNDL, RBN-133, STERILE, F/G
Version Model Number13 GAUGE x 3"
Catalog NumberRBN-133
Company DUNS121622872
Company NameRANFAC CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com

Device Dimensions

Needle Gauge13 Gauge
Length3 Inch
Needle Gauge13 Gauge
Length3 Inch
Needle Gauge13 Gauge
Length3 Inch
Needle Gauge13 Gauge
Length3 Inch
Needle Gauge13 Gauge
Length3 Inch
Needle Gauge13 Gauge
Length3 Inch

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM9797405003M0 [Primary]
HIBCCM9797405003M1 [Package]
Contains: M9797405003M0
Package: Inner Pack [10 Units]
Discontinued: 2025-11-20
Not in Commercial Distribution
HIBCCM9797405003M9 [Package]
Contains: M9797405003M1
Package: Case [12 Units]
Discontinued: 2025-11-20
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KNWInstrument, Biopsy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2025-11-21
Device Publish Date2017-05-08

Devices Manufactured by RANFAC CORP.

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M9797405003M9 - NDL, RBN-133, STERILE, F/G2025-11-21NDL, RBN-133, STERILE, F/G PN 74050-03M
M9797405003M9 - NDL, RBN-133, STERILE, F/G2025-11-21 NDL, RBN-133, STERILE, F/G PN 74050-03M
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10850075308047 - HYDRACELL-EXT-52025-10-03 HYDRACELL-EXT-5 F/G, STERILE P/N 77136-01M
10850075308061 - HYDRACELL-EXT-102025-10-03 HYDRACELL-EXT-10, F/G, STERILE P/N 77137-01M
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