Duns Number:191705904
Device Description: PE FILM GOWN A garment made of natural and/or synthetic materials intended to be worn over PE FILM GOWN A garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.
Catalog Number
68-6201-B
Brand Name
SURGIPLUS
Version/Model Number
1
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
Yes
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
OEA
Product Code Name
Non-Surgical Isolation Gown
Public Device Record Key
912db0a2-16a5-4d61-bfd9-bf8c6276893a
Public Version Date
July 17, 2020
Public Version Number
2
DI Record Publish Date
July 02, 2020
Package DI Number
70683534060529
Quantity per Package
15
Contains DI Package
00683534060520
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
dispenser
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 83 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 29 |