FDA.reportPublic FDA data

Barrx

Primary DI
20884521189420
Brand
Barrx
Company
Covidien LP
Model
CP-002A
Catalog number
CP-002A
Device description
RFA Cleaning Cap
Published
2016-09-24
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
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083711000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083711000MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34Barrx Medical, Incorporated2009-02-02GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521189420PackageGS110In Commercial Distribution
10884521189423PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452118942020884521189420
1088452118942310884521189423

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope tissue removal capA plastic tube designed to be placed onto the distal end of an endoscope (e.g., oesophagoscope) to facilitate the removal of coagulated blood/tissue from the path of the endoscope during endoscopic surgery. It is designed to fit tightly without fixing, having an oblique leading edge that extends beyond the end of the endoscope to provide atraumatic penetration and tissue removal functionality (e.g., scooping, grasping). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00;

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
false
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
00643169694859TrailBlazer™AngledASC-014-0902016-10-22
00643169694866TrailBlazer™AngledASC-014-1352016-10-22
00643169694873TrailBlazer™AngledASC-014-1502016-10-22
00643169694880TrailBlazer™AngledASC-018-0902016-10-22
00643169694897TrailBlazer™AngledASC-018-1352016-10-22
00643169694903TrailBlazer™AngledASC-018-1502016-10-22
00643169694910TrailBlazer™AngledASC-035-0652016-10-22
00643169694927TrailBlazer™AngledASC-035-0902016-10-22
00643169694934TrailBlazer™AngledASC-035-1352016-10-22
00643169694941TrailBlazer™AngledASC-035-1502016-10-22
00763000004804TrailBlazer™ AngledASC-014-0902017-12-22
00763000004811TrailBlazer™ AngledASC-014-1352017-12-22
00763000004828TrailBlazer™ AngledASC-014-1502017-12-22
00763000004835TrailBlazer™ AngledASC-018-0902017-12-22
00763000004842TrailBlazer™ AngledASC-018-1352017-12-22
00763000004859TrailBlazer™ AngledASC-018-1502017-12-22
00763000004866TrailBlazer™ AngledASC-035-0652017-12-22
00763000004873TrailBlazer™ AngledASC-035-0902017-12-22
00763000004880TrailBlazer™ AngledASC-035-1352017-12-22
00763000004897TrailBlazer™ AngledASC-035-1502017-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426354MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426385MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426422MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426545MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426552MillenniumAvalign Technologies, Inc.GEI2026-08-18
00198506093982ELMED INCORPORATEDELMED INCORPORATEDGEI2026-08-18
00841019123898KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-18
00840113234356BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237705BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237712BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07