FDA.report

Marina Medical

Primary DI
00840306808258
Brand
Marina Medical
Company
MARINA MEDICAL INSTRUMENTS, INC.
Model
340-252
Catalog number
340-252
Device description
Rectal Probe, LAP Style, Blue Handle, Ø24mm x 29.5cm
Published
2022-11-14
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
EXXPROBE, RECTAL, NON-POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
EXXProbe, Rectal, Non-PoweredGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840306808258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840306808258008403068082588403068082580840306808258

GMDN Terms

TermDefinition
Rectal probeA hand-held manual surgical instrument designed for exploring the tissues and structures of the rectum during a gastroenterological/urological surgical procedure. This is a reusable device.

Device Sizes

TypeValueUnit
Length29.5Centimeter

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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