FDA.report

Frazier Suction Handle 200 x 4mm OD (12Fg), fenestrated

Primary DI
05060212059109
Brand
Frazier Suction Handle 200 x 4mm OD (12Fg), fenestrated
Company
DTR MEDICAL LIMITED
Model
FSF2012
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
JOLCatheter And Tip, Suction

Product Code Classifications

CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060212059109PackageGS120In Commercial Distribution
05060212053701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060212059109050602120591095060212059109
05060212053701050602120537015060212053701

GMDN Terms

TermDefinition
Surgical/emergency suction cannula, non-illuminating, single-useAn atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
424066509
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05060212057563Sims Uterine SoundUSH20012024-10-14
05060212055460Aspiration Cannulae 70mm Angled, 1.4mm/17G74-1231A 2024-10-14
05060212055477Aspiration Cannulae 70mm Angled, 1.2mm/18G74-1232 2024-10-14
05060212055484Aspiration Cannulae 70mm Angled, 1.0mm/19G74-1232A 2024-10-14
05060212055576Aspiration Cannulae 70mm Angled, 0.9mm/20g74-1233 2024-10-14
05060212055583Aspiration Cannulae 70mm Angled, 0.7mm/22G74-1234 2024-10-14
05060212055590Aspiration Cannulae 70mm Angled, 0.55mm/24G74-1236 2024-10-14
05060212055606Aspiration Cannulae 80mm Angled, 2.0mm/14G74-1260 2024-10-14
05060212055613Aspiration Cannulae 80mm Angled, 1.0mm/19G74-1262A 2024-10-14
05060212055729Aspiration Cannulae 80mm Angled,1.4mm/17G74-1264 2024-10-14
05060212055736Aspiration Cannulae 70mm Angled, 1.6mm/16G74-12312024-10-14
05060212055743Aspiration Cannulae 80mm Angled, 1.7mm/15G74-12652024-10-14
05060212055750Aspiration Cannulae 80mm Angled, 2.5mm/13G74-1267 2024-10-14
05060212055767Aspiration Cannulae 80mm Angled, 3.0mm/11G74-12682024-10-14
05060212055873Aspiration Cannulae 100mm Angled, 3.0mm/11G74-1297 2024-10-14
05060212055910Brackmann type, 1.6mm x 115mm, 40 degree bend, suction control hole, open end74-2009 2024-10-14
05060212055927Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, without suction contro74-2011 2024-10-14
05060212056665Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012 2024-10-14
05060212057006Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012P 2024-10-14
05060212057013Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, with suction control h74-2013 2024-10-14

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