BrachyGel Vaginal Hydrogel Packing System

Primary DI
10841439114589
Brand
BrachyGel Vaginal Hydrogel Packing System
Company
MEDTEC, INC.
Model
RT-5300
Catalog number
RT-5300
Device description
BrachyGel Vaginal Hydrogel Packing System (BVHPS)
Published
2024-05-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QXRVaginal Hydrogel Packing System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QXRVaginal Hydrogel Packing SystemRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN220052000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN220052000BrachyGel Vaginal Hydrogel Packing SystemBrachyfoam, Inc. D/B/A Advaray2023-08-22QXR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841439114589PackageGS15In Commercial Distribution
00841439114582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084143911458910841439114589
00841439114582008414391145828414391145820841439114582

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal brachytherapy system applicator, manualA manual brachytherapy applicator specifically designed to be used in vaginal or transvaginal radiation therapy treatments. 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 accommodate individual patient source placement configurations and includes vaginal applicators such as hollow needles or tubes, catheters, ovoids or tandems, used in manual brachytherapy applications.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+17127378688regulatory@cqmedical.com

Regulatory Flags#

DUNS number
103977526
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
true
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
00841439113059Registration FilmPRO340PRO3402019-10-10
00841439114032Pediatric Registration FilmPRO440PRO4402022-08-20
00841439113240Solstice™ MR SRS Immobilization SystemCHS04MRCHS04MR2020-07-10
00841439110904RediFoam™MTFA41BMTFA41B2017-08-02
00841439110911RediFoam™MTFA40BMTFA40B2017-08-02
00841439110928RediFoam™MTFA39BMTFA39B2017-08-02
00841439101056Low Kneefix™ 23010483010482017-08-02
00841439101070Kneefix™ 33010523010522017-08-02
00841439101124Feetfix™ 33010713010712017-08-02
00841439102374Uni-frame® BaseplateMT20100MT201002017-08-02
00841439102411Uni-frame® BaseplateMT20104MT201042017-08-02
00841439102428Uni-frame® BaseplateMT20108MT201082017-08-02
00841439104163Type-S™ Variable Axis BaseplateMTCFHNVAB01MTCFHNVAB012017-08-02
00841439107003Prone-Lok™ Positioning CushionMTPLC01MTPLC012017-08-02
00841439109939Type-S™ Overlay1080731080732017-08-02
00841439110621Posifix® Variable Axis Baseplate1070651070652017-08-02
00841439111956Vac-Lok™ CushionVLWGB03VLWGB032018-05-07
00841439111963Vac-Lok™ CushionVLPLV02VLPLV022018-05-07
00841439111970Vac-Lok™ CushionVLPLV01VLPLV012018-05-07
00841439111987Vac-Lok™ CushionVLJ20VLJ202018-05-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841439114582BrachyGel Vaginal Hydrogel Packing SystemMEDTEC, INC.QXR2024-05-23