FDA.reportPublic FDA data

GOBEN

Primary DI
06979032640031
Brand
GOBEN
Company
HUZHOU JUNDA INDUSTRY CO., LTD.
Model
JD14-R490107
Device description
Closed Wound Drainage System, Silicone Drainage Kit 100ml Bulb Reservoir, Flat Drain 10mm, with Perforation, Sterile
Published
2025-08-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GBACatheter, Balloon Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBACatheter, Balloon TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16979032640038PackageGS110In Commercial Distribution
26979032640035PackageGS1100In Commercial Distribution
06979032640031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697903264003816979032640038
2697903264003526979032640035
06979032640031069790326400316979032640031

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric urethral stent, short-termA sterile non-bioabsorbable tubular device intended for short-term (<= 30 days) introduction into the urethra to facilitate urethral patency and an unimpeded flow of urine from the bladder, typically used during the postsurgical healing period [e.g., after thermal treatment of benign prostatic hyperplasia (BPH) or hypospadias/epispadias repair], or to relieve urethral obstruction from BPH and/or detrusor external sphincter dyssynergia (DESD). It is made entirely of a synthetic polymer(s) and may have various designs (e.g., continuous tube, meshed). It may be expandable in situ and disposable devices intended to assist implantation may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
452976115
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06979032640017GOBENJD12-U0301012025-08-26
06979032640024GOBENJD13-H0401012025-08-26
06979032640048GOBENJD14-R2801032025-08-26
06979032640055GOBENJD14-R4301062025-08-26
06979032640062GOBENJD05-N0801022025-08-26
06979032640079GOBENJD04-C1401052025-08-26
06979032640086GOBENJD05-N0401022025-08-26
06979032640093GOBENJD05-N2301062025-08-26
06979032640109GOBENJD01-B0102032025-08-26
06979032640116GOBENJD14-R3901012025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014541704EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
00860014541711EnvisionSPINAL STABILIZATION TECHNOLOGIES LIMITEDGBA2026-04-30
M7403150006VerifySPINEOLOGY INC.GBA2023-06-26
00887482173718Symmetry Surgical®ASPEN SURGICAL PRODUCTS, INC.GBA2022-09-21
00678467004963 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005007 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005847 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467005915 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006134 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006547 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006677 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006707 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467006868 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506184 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506252 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506276 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506337 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467506610 Mui Scientific H & A Mui Enterprises IncGBA2019-10-17
00678467001450Mui ScientificH & A Mui Enterprises IncGBA2019-10-16
00678467001627 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467001894 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467001924 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002150 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002358 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002426 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002549 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002600 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467002655 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467003058 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16
00678467003065 Mui Scientific H & A Mui Enterprises IncGBA2019-10-16