VERSAJET III PRECISION Hydrosurgery System Hand Piece 66802149

GUDID 05000223498160

VERSAJET III PRECISION HANDPIECE 45DEGx8MM

SMITH & NEPHEW MEDICAL LIMITED

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Primary Device ID	05000223498160
NIH Device Record Key	c3e50aa3-799e-47ab-95cc-df2b114c49a7
Commercial Distribution Status	In Commercial Distribution
Brand Name	VERSAJET III PRECISION Hydrosurgery System Hand Piece
Version Model Number	66802149
Catalog Number	66802149
Company DUNS	216344051
Company Name	SMITH & NEPHEW MEDICAL LIMITED
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0
Angle	45 degree
Device Size Text, specify	0

Operating and Storage Conditions

Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05000223498153 [Primary]
GS1	05000223498160 [Package] Contains: 05000223498153 Package: Case [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K220964

FDA Product Code

FQH	Lavage, Jet

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-06-08
Device Publish Date	2023-05-31

On-Brand Devices [VERSAJET III PRECISION Hydrosurgery System Hand Piece]

05000223498160	VERSAJET III PRECISION HANDPIECE 45DEGx8MM
05000223498146	VERSAJET III PRECISION HANDPIECE 45DEGx14MM
05000223498122	VERSAJET III PRECISION HANDPIECE 15DEGx14MM