RAN-1115N5B RAN-1115N5B

GUDID 00857878007972

NEEDLE, RAN-1115N5B F/G, STERILE, CE P/N: 74354-01M

RANFAC CORP.

Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula Bone access cannula
Primary Device ID00857878007972
NIH Device Record Key648708cf-0a64-471a-af5f-d0ec380f9650
Commercial Distribution StatusIn Commercial Distribution
Brand NameRAN-1115N5B
Version Model Number11Ga x 15CM
Catalog NumberRAN-1115N5B
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

Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com
Phone508-588-4400
Emailinfo@ranfac.com

Device Dimensions

Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter
Needle Gauge11 Gauge
Length15 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100857878007972 [Primary]
GS110857878007979 [Package]
Package: Inner Pack [1 Units]
In Commercial Distribution
GS120857878007976 [Package]
Contains: 10857878007979
Package: Case [30 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 Date2020-07-29
Device Publish Date2020-07-21

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10850023741865 - CER-BN-84-SCR2024-01-08 CER-BN-84-SCR, F/G, STERILE, P/N 74432-01M
00850023741875 - CER-SUB-15902023-12-21 CER-SUB-1590, F/G, STERILE, P/N 74433-01M
10850023741803 - RAN-15282023-11-28 NEEDLE, RAN-1528, F/G, STERILE, RANFAC P/N 74421-01M
10850023741810 - RBN-1332023-11-28 NEEDLE, RBN-133, F/G, STERILE, RANFAC P/N 74425-01M
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