Duns Number:123853058
Device Description: Ridge Preservation Kit - Cytoplast Technique; Includes: 1 sterile nonresorbable PTFE monof Ridge Preservation Kit - Cytoplast Technique; Includes: 1 sterile nonresorbable PTFE monofilament suture (model CS0518K) - USP 3-0, 18" length,16 mm 3/8 reverse cutting needle, 1 sterile nonresorbable PTFE membrane, textured (model TXT1224K) - 12 mm x 24 mm, 1 sterile GBM allograft (model C73050K) - 70% mineralized cortical bone matrix & 30% demineralized bone matrix
Catalog Number
-
Brand Name
Ridge Preservation Kit - Cytoplast Technique
Version/Model Number
KITRPCT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
Yes
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
-
Product Code Name
-
Public Device Record Key
02eb3dde-ccae-4fbd-9aa1-5df8263a596a
Public Version Date
May 07, 2019
Public Version Number
3
DI Record Publish Date
November 20, 2017
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 226 |