Duns Number:237799775
Device Description: Instrapac Delivery Pack with Drape and Large XRD swabs. 20 packs per Case.Contents: 1 x Um Instrapac Delivery Pack with Drape and Large XRD swabs. 20 packs per Case.Contents: 1 x Umbilical Cord Scissors 10cm/4in, 1 x Mayo Scissors Curved 17cm/6.75in, 2 x Spencer Wells Forceps Straight 18cm/7in, 2 x Umbilical Cord Clamps, 5 x Large XRD Swabs 30cm x 30cm (12in x 12in), 1 x Drape 90cm x 90cm (35in x 35in). Provided in a crepe paper wrap.
Catalog Number
8774
Brand Name
Instrapac
Version/Model Number
8774 Delivery Pack with Drape and Large XRD swabs
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
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
MLS
Product Code Name
Labor And Delivery Kit
Public Device Record Key
a1ba69b7-4f08-49d4-91f0-a1e40cab0850
Public Version Date
July 18, 2022
Public Version Number
3
DI Record Publish Date
November 26, 2020
Package DI Number
05010058187740
Quantity per Package
20
Contains DI Package
05010058087743
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case = 20 packs
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 84 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |