FDA.report

Centeze Centesis Catheter

Primary DI
20841268100415
Brand
Centeze Centesis Catheter
Company
GALT MEDICAL CORP.
Model
DRC-002-08
Catalog number
DRC-002-08
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

Related Records

Contact Domains

Product Codes

CodeName
KGZAccessories, Catheter

Product Code Classifications

CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10841268100418PackageGS110In Commercial Distribution
20841268100415PackageGS1100In Commercial Distribution
00841268100411PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1084126810041810841268100418
2084126810041520841268100415
00841268100411008412681004118412681004110841268100411

GMDN Terms

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

TypeValueUnit
Catheter Gauge5French

Sterilization Methods

Method
Ethylene Oxide

Contacts

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

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