FDA.reportPublic FDA data

Centeze Centesis Catheter

Primary DI
20841268100378
Brand
Centeze Centesis Catheter
Company
GALT MEDICAL CORP.
Model
DRC-002-04
Catalog number
DRC-002-04
Device description
Centeze Centesis Catheter
Published
2017-03-20
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
KGZAccessories, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841268100371PackageGS110In Commercial Distribution
20841268100378PackageGS1100In Commercial Distribution
00841268100374PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810037110841268100371
2084126810037820841268100378
00841268100374008412681003748412681003740841268100374

GMDN Terms#

Term, Definition table
TermDefinition
Closed-wound drainA sterile, tube-like device designed to establish a channel for the removal of fluid or purulent material from a closed-wound or an infected area, typically used with a closed drainage system that applies a low negative pressure through the drain lumen. It is typically made of silicone and comes in various designs/sizes for a wide variety of surgical applications (e.g., orthopaedic, plastic/reconstructive, neurological, gynaecological, thoracic, cardiovascular, and general surgery). It might include disposable devices dedicated to drain insertion/function (e.g., sharp metal trocar, connector), however it does not include any fluid collection bags/containers. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge4French

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
800-639-2800customerservice@galtneedletech.com

Regulatory Flags#

DUNS number
943156836
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841268108353Quiktork Guidewire Torque DeviceTOR-100-10TOR-100-102026-02-25
10841268108360Quiktork Guidewire Torque DeviceTOR-100-25TOR-100-252026-02-25
10841268110059Micro-Introducer KitKIT-100-00KIT-100-002026-01-19
10841268110066GuidewireSGW-071-01SGW-071-012026-01-19
10841268110073Hemostasis Valve AdapterGWT-001-00GWT-001-002026-01-19
10841268110080GuidewireSGW-074-00SGW-074-002026-01-19
10841268110097TVS LPAKIT-071-13LPA430SNS2026-01-19
10841268110110GuidewireSGW-071-02SGW-071-022026-01-19
10841268110127TVS LPAKIT-071-14KIT-071-142026-01-19
10841268110141DilatorDIL-616-08DIL-616-082026-01-19
10841268110332DilatorDIL-502-06DIL-502-062026-01-19
10841268110349Micro-Introducer KitKIT-100-01KIT-100-012026-01-19
10841268110356GuidewireSGW-071-03SGW-071-032026-01-19
10841268110363GuidewireSGW-022-69SGW-022-692026-01-19
10841268110387Micro-Introducer KitKIT-100-02KIT-100-022026-01-19
10841268110134GuidewireSGW-075-01BMG013-300DT2024-08-01
10841268109800Elite Transitionless Micro-Introducer KitKIT-098-01KIT-098-012022-08-15
10841268109817Elite Transitionless Micro-Introducer KitKIT-098-02KIT-098-022022-08-15
10841268109824Elite Transitionless Micro-Introducer KitKIT-098-03KIT-098-032022-08-15
10841268109831Elite Transitionless Micro-Introducer KitKIT-098-04KIT-098-042022-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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40198459435202MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
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05708932767545Insertion ToolCOLOPLAST CORP.KGZ2024-09-27
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