FDA.reportPublic FDA data

BRITE TIP

Primary DI
20705032000410
Brand
BRITE TIP
Company
CORDIS CORPORATION
Model
401855M
Catalog number
401855M
Device description
SI BRITE TIP 8F 55CM STR
Published
2016-08-01
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

Product Codes#

Code, Name table
CodeName
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K984500000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K984500000CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEMCordis Corp.1998-12-23DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705032000410PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503200041020705032000410

GMDN Terms#

Term, Definition table
TermDefinition
Haemostasis valveA sterile, noninvasive device with a self-sealing lumen (valve) designed as a conduit through which a small diameter diagnostic/interventional device (e.g., 25 French or less) can be introduced into or withdrawn from the patient's vasculature while maintaining haemostasis to reduce blood loss from the patient. It is intended to be attached, typically via Luer-lock, to an invasively-placed catheter introducer (not included) and typically has a sideport for the introduction of solutions. It may include noninvasive guidewire accessories (e.g., guidewire introducer, torque device). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if package is damanged
Special Storage Condition, Specify00Store in cool, dark, dry place

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
806136177
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
10705032000512AVANTI+402604T402604T2016-08-01
10705032000550AVANTI402605R402605R2016-08-01
10705032000772AVANTI+402611T402611T2016-08-01
10705032009751AVANTI504404X504404X2016-08-01
10705032009782AVANTI504407X504407X2016-08-01
10705032009805AVANTI504409X504409X2016-08-01
10705032009812AVANTI504504S504504S2016-08-01
10705032009829AVANTI504505S504505S2016-08-01
10705032009836AVANTI504505X504505X2016-08-01
10705032009843AVANTI504506S504506S2016-08-01
10705032009850AVANTI504506X504506X2016-08-01
10705032009867AVANTI504507X504507X2016-08-01
10705032009874AVANTI504508X504508X2016-08-01
10705032009928AVANTI504604T504604T2016-08-01
10705032009973AVANTI504605T504605T2016-08-01
10705032010009AVANTI504606D504606D2016-08-01
10705032010016AVANTI504606P504606P2016-08-01
10705032010023AVANTI504606S504606S2016-08-01
10705032010030AVANTI504606T504606T2016-08-01
10705032010054AVANTI504606X504606X2016-08-01

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Primary DI, Brand, Company table
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10884450114855Prelude IDeal™Merit Medical Systems, Inc.DYB2026-06-08
00850084947001Genie MAXCULTIV8 1, LLCDYB2026-05-29
G440VIZ1750MultiflexVizaramed, Inc.DYB2026-04-09
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