FDA.reportPublic FDA data

RANR-1115N5T

Primary DI
20857878007013
Brand
RANR-1115N5T
Company
RANFAC CORP.
Model
11 GA x 150MM
Catalog number
RANR-1115N5T
Device description
RANR-1115N5T PN 74189-15M
Published
2017-06-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWInstrument, Biopsy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131157000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131157000RANFAC BONE MARROW ASPIRATION NEEDLERanfac, Corp.2013-10-22KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857878007016PackageGS110In Commercial Distribution
20857878007013PackageGS18In Commercial Distribution
00857878007019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085787800701610857878007016
2085787800701320857878007013
00857878007019008578780070198578780070190857878007019

GMDN Terms#

Term, Definition table
TermDefinition
Bone access cannulaA sterile, sharp, hollow tubular metal instrument designed for percutaneous insertion to provide access to any bone of the body for a bone biopsy needle or guidewire, or for a bone marrow aspiration technique, or for inserting therapeutic materials, including bone cements. It is typically inserted using a stylet under imaging [e.g., fluoroscopic, ultrasonic, computed tomography (CT)] control and has a proximal plastic handgrip to apply manual pressure and twist. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Needle Gauge11Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5085884400info@ranfac.com

Regulatory Flags#

DUNS number
121622872
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850023741226Cervos Flex Bone Marrow Aspiration Needle8 Gauge x 9.1cmCER-FLEX2021-07-16
00850023741462CER-LA11 GA X 16.5 CMCER-LA2021-11-10
00850023741479CER-FLEX8 GA X 9.1 CMCER-FLEX2021-11-10
00858690006808Cervos Lipo Pro Double PackCER-LP-40CER-LP-402022-09-19
00850023741561CERVOS PLATELET SEPARATOR 80 KITCER-PRP-80CER-PRP-802026-03-30
00850075308088CER-PRP-160 STERILITY PACKCER-PRP-160-SCER-PRP-160-S2026-03-30
00850075308101CER-PRP-160 KitCER-PRP-160CER-PRP-1602026-03-30
00850075308163CER-PRP-40 KIT F/G, STERILECER-PRP-40CER-PRP-402026-03-30
M9797405001M0NDL, RBN-114, STERILE, F/G"11 GAUGE x 4"""RBN-1142017-05-08
M9797405003M0NDL, RBN-133, STERILE, F/G"13 GAUGE x 3"""RBN-1332017-05-08
M9797405005M0NDL, RBN-132"13 GAUGE x 2"""RBN-1322017-05-08
M9797405006M0NDL, RBN-84, STERILE, F/G"8 GAUGE x 4"""RBN-842017-05-08
M9797405001M9NDL, RBN-114, STERILE, F/G11 GAUGE x 4"RBN-1142017-05-08
M9797405003M9NDL, RBN-133, STERILE, F/G13 GAUGE x 3"RBN-1332017-05-08
M9797405005M9NDL, RBN-13213 GAUGE x 2"RBN-1322017-05-08
00850075308095CER-PRP-SINGLE-ACER-PRP-SINGLE-ACER-PRP-SINGLE-A2025-10-08
00850075308019HYDRACELL-ORTHO-511 Gauge x 6.1CM 5ccHYDRA-ORTHO-52025-09-25
00850075308033HYDRACELL-ORTHO-1011 Gauge x 6.1CM 10ccHYDRA-ORTHO-102025-09-25
00850075308040HYDRACELL-EXT-511 Gauge x 6.3 CM 5ccHYDRA-EXT-52025-09-25
00850075308064HYDRACELL-EXT-1011 Gauge x 6.3 CM 10ccHYDRA-EXT-102025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800025901151BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
08800025902059BEXCORE Breast Biopsy SystemMedicalPark CO.,LTD.KNW2026-06-01
06937278635983CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278635990CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636003CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636010CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636027CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636034CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636041CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636058CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636065CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636072CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636089CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636096CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636102CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636119CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636126CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636133CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636140CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636157CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636164CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636171CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636188CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636195CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636201CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636218CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636225CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636232CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636249CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31
06937278636256CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-05-31