FDA.report

FENTEX

Primary DI
04250407705183
Brand
FENTEX
Company
FENTEX medical GmbH
Model
049703FX
Catalog number
049703FX
Device description
Antrum Cannula by Van Eicken long curved, Luer-Lock 15 cm, Ø 3 mm
Published
2022-12-07
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

Product Codes

CodeName
LRCINSTRUMENT, ENT MANUAL SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250407705183PrimaryGS10

GMDN Terms

TermDefinition
Surgical irrigation/aspiration cannula, non-illuminating, reusableAn atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+4974679496212s.renner@fentexmedical.com

Regulatory Flags

DUNS number
507221724
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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04250407786670FENTEX118970FX118970FX2024-12-28
04250407786731FENTEX540725FX540725FX2024-10-18
04250407786748FENTEX540726FX540726FX2024-10-18
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04250407786762FENTEX540728FX540728FX2024-10-18
04250407731571FENTEX363600FX363600FX2022-12-12
04250407731816FENTEX379100FX379100FX2022-12-12
04250407785116FENTEX540700FX540700FX2024-08-01
04250407785314FENTEX540705FX540705FX2024-08-01
04250407785321FENTEX540710FX540710FX2024-08-01

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