Duns Number:081253414
Device Description: INFINIX & LUMINARY HEAD HOLDER KIT. Includes: 9402 - INFINIX MANDIBULAR SUPPORT PADS (1081 INFINIX & LUMINARY HEAD HOLDER KIT. Includes: 9402 - INFINIX MANDIBULAR SUPPORT PADS (10810050242735), 9403 – FOREHEAD PAD KIT (00810050243223), 9404 – CHIN STRAP (00810050241311), 9405 - INFINIX NECK SUPPORT PADS (00810050243230), 9406 – ARM SUPPORT (10810050242728), 9407 – KNEE SUPPORT (00810050241335), 9408 - INFINIX HEAD SUPPORT PAD (00810050241328), 20252 – TABLE PAD (00810050241250)
Catalog Number
-
Brand Name
N/A
Version/Model Number
9401
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
a6a0da52-b58e-4cda-a2d8-9ec9c1222f8e
Public Version Date
October 02, 2020
Public Version Number
1
DI Record Publish Date
September 24, 2020
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 | 512 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 35 |