FDA.report

Marina Medical

Primary DI
00840306823787
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
201-062
Catalog number
201-062
Device description
Molt Mouth Gag - 12cm, Child"
Published
2024-04-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306823787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306823787008403068237878403068237870840306823787

GMDN Terms

TermDefinition
Mouth gag support, reusableA non-sterile frame-like device intended to support a mouth gag over/near a patient’s mouth during dental, anaesthesia, or ENT procedures. It consists of three interlocking components: a strip with a central line of holes and two rods with rings at one end which can be aligned to accept the supporting hook of the mouth gag. Otherwise known as a Draffin Bipod, the arrangement provides a configurable support at variable heights. This is a reusable device.

Device Sizes

TypeValueUnit
Length12Centimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(954)924-4419enrico@marinamedical.com
+1(954)924-4418enrico@marinamedical.com

Regulatory Flags

DUNS number
011442279
Device count
1
DM exempt
false
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
true

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