FDA.report

Gen2

Primary DI
00840343704841
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2N28042
Catalog number
G2N28042
Device description
MULTI-HOLE SUCTION TUBE 6.50" 5 FR
Published
2022-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JOLCatheter And Tip, Suction

Product Code Classifications

CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G277G2N280420PreviousHIBCC0
00840343704841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343704841008403437048418403437048410840343704841

GMDN Terms

TermDefinition
Suction system catheter, general-purposeA sterile flexible tube used in the removal of fluids from the body via a natural body orifice, surgical incision, or wound. It is typically designed to be attached to a collection canister or bottle where a vacuum is created by a suction system via an intermediate tubing. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length6.5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags

DUNS number
080402644
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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