CER-SUB-1590 CE CER-SUB-1590

GUDID 10850023741995

CER-SUB-1590, CE, F/G, STERILE, P/N 74439-01M

RANFAC CORP.

Bone access cannula
Primary Device ID10850023741995
NIH Device Record Key7938cf09-ae59-4817-96b6-aea92258f36a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCER-SUB-1590 CE
Version Model Number15 GA X 90 MM
Catalog NumberCER-SUB-1590
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 Datetrue
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
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com
Phone5085884400
Emailinfo@ranfac.com

Device Dimensions

Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter
Needle Gauge15 Gauge
Length90 Millimeter

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
GS100850023741998 [Primary]
GS110850023741995 [Package]
Contains: 00850023741998
Package: INNER PACK [1 Units]
In Commercial Distribution
GS120850023741992 [Package]
Package: CASE [24 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 Date2024-10-25
Device Publish Date2024-10-17

Devices Manufactured by RANFAC CORP.

10850023741995 - CER-SUB-1590 CE2024-10-25CER-SUB-1590, CE, F/G, STERILE, P/N 74439-01M
10850023741995 - CER-SUB-1590 CE2024-10-25 CER-SUB-1590, CE, F/G, STERILE, P/N 74439-01M
10850023741988 - Cervos Platelet Single B2024-09-18 CER-PRP-SINGLE-B F/G, STERILE PN: 76133-01M
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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