FDA.report

Gen2

Primary DI
00840343719456
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E901121
Catalog number
G2E901121
Device description
SCHUKNECHT SUCTION TUBE 20G
Published
2023-11-14
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
00840343719456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343719456008403437194568403437194560840343719456

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.

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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