FDA.reportPublic FDA data

CT/MR Split-Rng B-U,5mmx7.5mm,reus,SET

Primary DI
00817330023643
Brand
CT/MR Split-Rng B-U,5mmx7.5mm,reus,SET
Company
MICK RADIO NUCLEAR INSTRUMENT, INC
Model
1305-01-02
Catalog number
1305-01-02
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
JAQSystem, Applicator, Radionuclide, Remote-Controlled

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAQSystem, Applicator, Radionuclide, Remote-ControlledRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063382000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063382000HDR CT COMPATIBLE SPLIT RING APPLICATORMick Radio-Nuclear Instruments, Inc.2006-12-26JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817330023643PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817330023643008173300236438173300236430817330023643

GMDN Terms#

Term, Definition table
TermDefinition
Cervical/intrauterine brachytherapy system applicator, manualA manual brachytherapy applicator specifically designed to be used in cervical and/or intrauterine radiation therapy treatments. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, endoscopically guided placement or diagnostic imaging system guided placement, of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to accommodate individual patient source placement configurations and includes cervical/intrauterine applicators such as hollow needles, tubes or catheters, used in manual brachytherapy applications.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
073260622
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817330028082CT/MR M.A.C. Template - 14cm Vaginal Obturator with Lock Screw - 2.0mm Needle0918-05-2.02023-11-02
00817330022776CT/MR 2/3 Channel Endometrial Applicator Set, Nucletron091609162017-01-24
00817330026774Pathfinder 15.5G, 20cm9807PFO-15.5-209807PFO-15.5-202017-01-11
00817330027696Smit Sleeve w/Titanium Ring 40mm0311-40mm0311-40mm2016-11-08
00817330027870CT/MR Miami Buildup Cap, 40mm,open end, Varian0904-02-400904-02-402017-01-30
00817330027979CT/MR M.A.C. Vaginal Obturator 14cm Length with Lock Screw 1.65G0918-14-1.650918-15-1.652017-05-15
00817330020000Henschke Ovoids With Tungsten Segments & Caps Set6402-056402-052016-10-05
00817330020017Miami-Style Applicator Set, Varian (Non-CT/MR)010401042016-10-14
00817330020031CT/MR Miami Build-Up Cap/ Obturator - 30mm0104-02-300104-02-302016-10-14
00817330020062Extended Lock Nut0104-100104-102016-10-14
00817330020079Miami Stump Plug Insertion Tool0104-290104-292016-10-14
00817330020086Miami Stump Plug0104-300104-302016-10-14
00817330020109Non-CT Miami Build-Up Cap Domed 25mm Varian0104-40-300104-40-302016-10-14
00817330020123Non-CT Miami Build-Up Cap Domed 35mm Varian0104-40-350104-40-352016-10-14
00817330020130Non-CT Miami Build-Up Cap Domed 40mm Varian0104-40-400104-40-402016-10-14
00817330020147Build-up Cap for Ring & Tandem, 5.0mm (black)0213-63-10213-63-12016-10-14
00817330020154Build-up Cap for Ring & Tandem, 7.5mm (white)0213-63-20213-63-22016-10-14
00817330020161CT/MR Ring & Tandem Set, 32mm, 30°,45°,60°, Varian040704072016-09-20
00817330020185CT/MR Ring & Tandem Set, 32mm Ring, 30ø, Varian0407-300407-302016-09-20
00817330020192CT/MR Ring & Tandem IU Tube, 30ø, 2cm, Varian0407-30-20407-30-22016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08717213014305NANucletron B.V.JAQ2019-02-02
08717213008472Shielded Cylindrical ApplicatorNucletron B.V.JAQ2018-07-11
08717213008892NANucletron B.V.JAQ2018-07-11
08717213008908NANucletron B.V.JAQ2018-07-11
08717213008915NANucletron B.V.JAQ2018-07-11
08717213009578Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009585Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213009646Miami Vaginal ApplicatorNucletron B.V.JAQ2018-07-11
08717213007772Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007796Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213007826Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009660Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009677Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213009691Fletcher Williamson ApplicatorNucletron B.V.JAQ2018-07-06
08717213010000Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213010024Flexible Implant TubesNucletron B.V.JAQ2018-07-06
08717213009318Esophageal ApplicatorNucletron B.V.JAQ2018-06-27
08717213010666Flexible Implant TubesNucletron B.V.JAQ2018-06-27
08717213007765Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009042Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213009059Esophageal ApplicatorNucletron B.V.JAQ2018-06-20
08717213013926Vaginal CT/MR ApplicatorNucletron B.V.JAQ2018-06-20
08717213008274MicroSelectron DigitalNucletron B.V.JAQ2018-06-14
08717213014022Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014039Standard CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014145Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014152Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014169Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014206Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09
08717213014213Ring CT/MR ApplicatorNucletron B.V.JAQ2018-06-09