FDA.report

Silicone Evacuator Kit

Primary DI
20801741050064
Brand
Silicone Evacuator Kit
Company
C. R. Bard, Inc.
Model
0073320
Catalog number
0073320
Device description
100cc Silicone Evacuator Kit, Medium-Large 3/16" (15Fr., 4.7mm) O.D. Silicone Round Drain with X-Ray Opaque Stripe, 49" (124.4cm) Length, 10" (25.4cm) Hole Pattern, Attached Trocar, 100cc Silicone Evacuator with Anti-Reflux Valve
Published
2020-09-22
Public version status
New
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
GCYAPPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Product Code Classifications

CodeDeviceSpecialtyClass
GCYApparatus, Suction, Single Patient Use, Portable, NonpoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741050067PackageGS110In Commercial Distribution
20801741050064PackageGS12In Commercial Distribution
00801741050060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174105006710801741050067
2080174105006420801741050064
00801741050060008017410500608017410500600801741050060

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 Gauge15French
Length49Inch

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)526-4455medical.services@crbard.com

Regulatory Flags

DUNS number
016898496
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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