RAN-11-1 RAN-11-1

GUDID 00857878007460

NEEDLE, RAN-11-1, F/G, STERILE P/N 74086-01M

RANFAC CORP.

Bone access cannula
Primary Device ID00857878007460
NIH Device Record Keycc95a7f8-b3c8-4661-a59c-374fdc3f711f
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAN-11-1
Version Model Number11 Gauge x 11CM
Catalog NumberRAN-11-1
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
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com

Device Dimensions

Needle Gauge11 Gauge
Length11 Centimeter
Needle Gauge11 Gauge
Length11 Centimeter
Needle Gauge11 Gauge
Length11 Centimeter
Needle Gauge11 Gauge
Length11 Centimeter
Needle Gauge11 Gauge
Length11 Centimeter
Needle Gauge11 Gauge
Length11 Centimeter
Needle Gauge11 Gauge
Length11 Centimeter
Needle Gauge11 Gauge
Length11 Centimeter
Needle Gauge11 Gauge
Length11 Centimeter
Needle Gauge11 Gauge
Length11 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100857878007460 [Primary]
GS110857878007467 [Package]
Package: Case [120 Units]
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-24
Device Publish Date2021-09-16

Devices Manufactured by RANFAC CORP.

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10857878007313 - MAXX-CELL-32024-09-17 MAXX-CELL Bone Marrow Aspirate Kit w/ Biopsy Needle 11GA X 11CM MAX-CELL Needle 8GA X 15CM RJN-815 PN 74408-01M
10850023741964 - BANRAN-112024-07-18 BANRAN-11, F/G, STERILE, P/N 76153-01M
10850023741896 - CER-PRP-JUVA 2024-05-23 CER-PRP-JUVA F/G, STERILE PN: 76145-01M
00850023741929 - CER-JUVA-BD ASSEMBLY2024-05-23 CER-JUVA-BD Assembly PN 69014-01M
00850023741936 - CER-PRP-JUVA-KIT2024-05-23 CER-PRP-JUVA-KIT F/G, STERILE PN: 76152-01M
10850023741957 - MC-RAN-BZL-8C2024-05-14 MC-RAN-BZL-8C F/G, STERILE, P/N 74431-01M

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