FDA.reportPublic FDA data

ROEKO Surgitip

Primary DI
E1654620250
Brand
ROEKO Surgitip
Company
Coltène/Whaledent GmbH + Co. KG
Model
462025
Catalog number
462025
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOLCatheter And Tip, Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOLCatheter And Tip, SuctionGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E1654620250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental suction system cannula, single-useA semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter6.5Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep away from sunlight
Special Storage Condition, Specify00keep dry
Storage Environment Temperature2 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature37 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4973458050info.de@coltene.com

Regulatory Flags#

DUNS number
315494443
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E165H021220HYGENIC® Paper PointsH03180H031802023-02-13
E165H021230HYGENIC® Paper PointsH02123H021232023-02-13
E165H021240HYGENIC® Paper PointsH02124H021242023-02-13
E165H021300HYGENIC® Paper PointsH02130H021302023-02-13
E165H021310HYGENIC® Paper PointsH02131H021312023-02-13
E165H031870HYGENIC® Paper PointsH03187H031872023-02-13
E165H031880HYGENIC® Paper PointsH03188H031882023-02-13
E165H031890HYGENIC® Paper PointsH03189H031892023-02-13
E165H031900HYGENIC® Paper PointsH03190H031902023-02-13
E165H031910HYGENIC® Paper PointsH03191H031912023-02-13
E165H031980HYGENIC® Paper PointsH03198H031982023-02-13
E165H076770HYGENIC® Paper PointsH07677H076772023-02-13
E165H076780HYGENIC® Paper PointsH07678H076782023-02-13
E165H076790HYGENIC® Paper PointsH07679H076792023-02-13
E165H076800HYGENIC® Paper PointsH07680H076802023-02-13
E165H076810HYGENIC® Paper PointsH07681H076812023-02-13
E165H076820HYGENIC® Paper PointsH07682H076822023-02-13
E165H076830HYGENIC® Paper PointsH07683H076832023-02-13
E165H076840HYGENIC® Paper PointsH07684H076842023-02-13
E165H076850HYGENIC® Paper PointsH07685H076852023-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800157Adler Instrument CompanyAdler, Inc.JOL2026-05-26
40080196035435MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-16
40080196995555MEDLINEMEDLINE INDUSTRIES, INC.JOL2026-03-13
00192896122802Frazier Suction TubeSONTEC INSTRUMENTS, INC.JOL2026-03-10
00810130207336MSIModern Surgical Instruments LLCJOL2026-01-23
16931918174334AllesetGRI Medical & Electronic Technology Co., Ltd.JOL2026-01-21
50192253039670CARDINAL HEALTHCardinal Health 200, LLCJOL2025-12-16
00840343727178GEN2SURGIX MEDICAL LLCJOL2025-12-11
16974500613491Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
16974500613507Orthopedic Suction SetGCMEDICA ENTERPRISE LTD.(WUXI)JOL2025-12-04
57613327680725Q-CareSAGE PRODUCTS, LLCJOL2025-12-03
30889483563414BALLARD™SUNMED, LLCJOL2025-12-01
30889483564978BALLARD™SUNMED, LLCJOL2025-12-01
30889483565562BALLARD™SUNMED, LLCJOL2025-12-01
00840314238511gSourceGSOURCE LLCJOL2025-11-24
00840314238528gSourceGSOURCE LLCJOL2025-11-24
00840314238535gSourceGSOURCE LLCJOL2025-11-24
00840314238542gSourceGSOURCE LLCJOL2025-11-24
00840314238559gSourceGSOURCE LLCJOL2025-11-24
00840314238566gSourceGSOURCE LLCJOL2025-11-24
00840314238573gSourceGSOURCE LLCJOL2025-11-24
00840314238580gSourceGSOURCE LLCJOL2025-11-24
00840314238597gSourceGSOURCE LLCJOL2025-11-24
00840314238603gSourceGSOURCE LLCJOL2025-11-24
00840314238610gSourceGSOURCE LLCJOL2025-11-24
00840314238627gSourceGSOURCE LLCJOL2025-11-24
00840314238634gSourceGSOURCE LLCJOL2025-11-24
00840314238641gSourceGSOURCE LLCJOL2025-11-24
00840314238658gSourceGSOURCE LLCJOL2025-11-24
00840314238665gSourceGSOURCE LLCJOL2025-11-24