FDA.reportPublic FDA data

Intrauterine tandem, 40mm, 30ø, titanium

Primary DI
00817330026927
Brand
Intrauterine tandem, 40mm, 30ø, titanium
Company
MICK RADIO NUCLEAR INSTRUMENT, INC
Model
AL07365040
Catalog number
AL07365040
Published
2016-10-14
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
K030110000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030110000CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTORMick Radio-Nuclear Instruments, Inc.2003-04-03JAQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817330026927PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817330026927008173300269278173300269270817330026927

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose brachytherapy system applicator, manualA general-purpose brachytherapy applicator designed to facilitate delivery of radiation therapy treatments that are not specific to a particular anatomical region. It is an individual or modular device designed to facilitate manual placement, e.g., puncture, topical placement, endoscopically guided placement or diagnostic imaging system guided placement, and removal of single or multiple radioactive sources at a treatment site. The device may be a fixed design or designed to facilitate the creation of variable physical configurations or individual patient source placement configurations and includes general-purpose applicators such as hollow needles, tubes or catheters, ovoids or tandems.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
073260622
Device count
1
DM exempt
true
Lot or batch
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
00816389028081MAASTRO Rectal Applicator Set, ø 26 mmVARIAN MEDICAL SYSTEMS, INC.JAQ2026-06-02
00816389029460Intrauterine tandem, 15 degrees, 2 cm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029637Ovoid, 40 mm, pair, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389029712Retractor, 30 mm, CT/ MRVARIAN MEDICAL SYSTEMS, INC.JAQ2025-05-16
00816389020276Crook Prostate Template for 17 gauge (1.47 mm) needlesVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-19
00810563022025Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrinVARIAN MEDICAL SYSTEMS, INC.JAQ2024-02-16
00816389029217Stainless steel needle 113mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389029224Stainless steel needle 200mm, 17 gauge, trocar pointVARIAN MEDICAL SYSTEMS, INC.JAQ2023-04-28
00816389028869VariSource VS2000 HDR Ir 192 Brachytherapy Sealed SourceVARIAN MEDICAL SYSTEMS, INC.JAQ2022-01-09
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