FDA.report

Site-Rite

Primary DI
20801741037799
Brand
Site-Rite
Company
Bard Access Systems, Inc.
Model
9001896
Catalog number
9001896
Device description
18G NG Kit with 96in Probe Cover (10 pk)
Published
2016-09-14
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
ITXTransducer, ultrasonic, diagnostic

Product Code Classifications

CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741037792PackageGS110In Commercial Distribution
20801741037799PackageGS112In Commercial Distribution
00801741037795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103779210801741037792
2080174103779920801741037799
00801741037795008017410377958017410377950801741037795

GMDN Terms

TermDefinition
Cable/lead/sensor/probe cover, sterileA sterile device, typically made of disposable plastic, that forms a protective enclosure around its cable/lead, probe, sensor, or tube contents, making a hygienic barrier so that the non-sterile contents may enter a hygienic area, e.g., a sterile surgical field. This is a single-use device.

Device Sizes

TypeValueUnit
Length96Inch
Needle Gauge18Gauge

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)545-0890medical.services@crbard.com

Regulatory Flags

DUNS number
044611812
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
true
Sterilization required before use
false

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