Duns Number:480420090
Device Description: 1 sterilisable aluminium case 185x145x30mm1 Stainless steel syringe1 Surgery needle N°1/R 1 sterilisable aluminium case 185x145x30mm1 Stainless steel syringe1 Surgery needle N°1/R Red + N°0/R Yellow 1 Surgery needle N°1/L Red + N°0/L Yellow 1 Niti Memory shape Needle N°1 Red + N°0 Yellow24 spare POM plungers (3x8) N°1 Red + (3x8) N°0 Yellow1 Niti cleaning curette N°1 Red + N°0 Yellow1 paste cleaing device stops N°1 Red + N°0 Yellow 1 Stainless steel weel diam 14mm
Catalog Number
-
Brand Name
MAP SYSTEM, SURGICAL KIT
Version/Model Number
20287
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EKI
Product Code Name
Carrier, Amalgam, Operative
Public Device Record Key
76a32911-54b5-4f84-9a66-76524844ee1d
Public Version Date
June 29, 2022
Public Version Number
1
DI Record Publish Date
June 21, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 278 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |