Duns Number:002348191
Device Description: White Blue Co-braid Polyethylene Size 0 20" HR17X CRE
Catalog Number
150703-CRE
Brand Name
BLUESTITCH
Version/Model Number
IPN028393
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
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
GAT
Product Code Name
SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
Public Device Record Key
a5eceba5-d2b6-4d5d-a33d-ce6d4094059f
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
January 15, 2019
Package DI Number
34026704626503
Quantity per Package
12
Contains DI Package
44026704626500
Package Discontinue Date
November 10, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |