FDA.reportPublic FDA data

Sun Medical INc

Primary DI
B226843000
Brand
Sun Medical INc
Company
SUN MEDICAL INC
Model
84300
Catalog number
84300
Device description
Disposable Swivel Handle for use with Aspirator Tubing and Cannula
Published
2017-01-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDBExtractor, Vacuum, Fetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDBExtractor, Vacuum, FetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B226843000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suction cannula, single-useA sterile, rigid or semi-rigid, hand-held plastic tube designed as a conduit for the evacuation (suctioning) of blood, fluids, and other tissue debris directly from the surgical site during a surgical procedure (e.g., open- or plastic surgery). Also known as a suction tube, it is typically a general-purpose device to which the suction system tubing is connected proximally; some types may be attached to a dedicated handpiece that typically have a valve. Dedicated cannula specifically intended for a particular procedure (e.g., bronchial, dental, eye, uterine, oral, and liposuction) are also available. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
9033569000Spolk@sunmedicalinc.com

Regulatory Flags#

DUNS number
095223103
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B22687300000Sun Medical Inc873000087300002017-01-23
B22687300001Sun Medical Inc873000087300002017-01-23
B22691200000Sun Medical IncSFE20091200002017-01-23
B226841080Sun Medical Inc84108841082016-08-02
B226841082Sun Medical Inc84108841082017-01-23
B226841100Sun Medical Inc84110841102017-01-23
B226841102Sun Medical Inc84110841102017-01-23
B226841120Sun Medical Inc84112841122017-01-23
B226841122Sun Medical Inc841128411222017-01-23
B226841140Sun Medical Inc84114841142017-01-23
B226841142Sun Medical Inc84114841142017-01-23
B226842080Sun Medical Inc84208842082017-01-23
B226842082Sun Medical Inc84208842082017-01-23
B226842100Sun Medical Inc84210842102017-01-23
B226842102Sun Medical Inc84210842102017-01-23
B226842120Sun Medical Inc84212842122017-01-23
B226842122Sun Medical Inc84212842122017-01-23
B226842140Sun Medical Inc84214842142017-01-23
B226842142Sun Medical Inc84214842142017-01-23
B226843002Sun Medical Inc84300843002017-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814247021243Kiwi® OmniCup®CLINICAL INNOVATIONS, LLCHDB2025-12-16
07612367000109Silicone tubing ID 6.5mm, 180cm, 1 coupling pieceMedela AGHDB2024-05-31
07612367003551Quiver 280mmMedela AGHDB2024-05-31
07612367003568Quiver 480mmMedela AGHDB2024-05-31
07612367003575Change over valveMedela AGHDB2024-05-31
07612367003698Overflow protection deviceMedela AGHDB2024-05-31
07612367003735Reusable serial connectorMedela AGHDB2024-05-31
07612367003742Safety Set for railholderMedela AGHDB2024-05-31
07612367003896Tubing holder left sideMedela AGHDB2024-05-31
07612367003902Tubing holder right sideMedela AGHDB2024-05-31
07612367004275Silicone tube, ID 7mm, 100cmMedela AGHDB2024-05-31
07612367004688Holder for 1L/1.5L jar, leftMedela AGHDB2024-05-31
07612367004695Holder for 1L/1.5L jar, rightMedela AGHDB2024-05-31
07612367004701Holder for 2L/2.5L jar, leftMedela AGHDB2024-05-31
07612367004718Holder for 2L/2.5L jar, rightMedela AGHDB2024-05-31
07612367008242Double conical coupling pieceMedela AGHDB2024-05-31
07612367008655Silicone tube, ID 7mm, 33cmMedela AGHDB2024-05-31
07612367009928Y-pieceMedela AGHDB2024-05-31
07612367011204Vario Filter set, bacteria & overflowMedela AGHDB2024-05-31
07612367011372Single set 1lMedela AGHDB2024-05-31
07612367011389Single set 2lMedela AGHDB2024-05-31
07612367011600Single set 2l, clampholderMedela AGHDB2024-05-31
07612367017329Single set 1l, clampholderMedela AGHDB2024-05-31
07612367017336Single set 3l, clampholderMedela AGHDB2024-05-31
07612367017343Single set 5l, clampholderMedela AGHDB2024-05-31
07612367017350Double set 3lMedela AGHDB2024-05-31
07612367017367Double set 5lMedela AGHDB2024-05-31
07612367038225Double set 2lMedela AGHDB2024-05-31
07612367047692Trolley A for DCSMedela AGHDB2024-05-31
07612367051033Trolley B for DCSMedela AGHDB2024-05-31