FDA.report

Marina Medical

Primary DI
00840306808203
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
340-215
Catalog number
340-215
Device description
Marina Obturator 3mm, 5.5cm Length
Published
2022-11-10
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

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306808203PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306808203008403068082038403068082030840306808203

GMDN Terms

TermDefinition
Surgical drill guide obturatorA surgical device designed to fill the lumen of a drill guide during its insertion to a surgical site primarily to prevent tissue obstruction of the drill guide lumen. When the drill guide is firmly placed at the chosen position on the bone surface, the obturator is removed. It is typically a rod with a rounded distal end, which protrudes out of the drill guide, and a knob-like handle that functions as a regulator to control the length of the protruding end and to remove it from the drill guide. It is typically made of a high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Length5.5Centimeter

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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