FDA.report

Marina Medical

Primary DI
00840306808449
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
350-395
Catalog number
350-395
Device description
Stubbs Popsicle Stent, Large, 15cm
Published
2022-11-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GADRETRACTOR
HDQDILATOR, CERVICAL, FIXED SIZE

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
HDQDilator, Cervical, Fixed SizeObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306808449PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306808449008403068084498403068084490840306808449

GMDN Terms

TermDefinition
Polymeric vaginal stent, non-bioabsorbableA sterile non-bioabsorbable tubular device intended for long-term placement in the vagina to provide structural support and/or prevent shrinking. It is typically used for vaginal dilation following surgical or non-surgical treatment of vaginal agenesis or transgender vaginoplasty, or for the prevention of vaginal contracture or stenosis after radiotherapy. It is made of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., inflatable tubular envelope with valves and internal drains, semi-soft moulded tube). This is a single-patient use device that can be reapplied to the patient during the treatment period (e.g., nightly) before being discarded (reusable).

Device Sizes

TypeValueUnit
Length15Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags

DUNS number
011442279
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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