FDA UDI In Commercial Distribution 🇺🇸 United States

Expo model gown (length 135 cm) size XXL

DI: 08056646507238 · Model: 30.D1277.00 · OMNIA SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Basic Information

Brand Name
Expo model gown (length 135 cm) size XXL
Primary DI
08056646507238
Version / Model
30.D1277.00
Company Name
OMNIA SRL
Labeler DUNS
447696675
Distribution Status
In Commercial Distribution
Device Count in Pkg
12
Record Status
Published
Publish Date
2023-06-22
Public Version
1
Public Version Date
2023-06-30
Public Version Status
New
Public Device Record Key
d95b71b5-cdb8-4733-93ed-8230dcb1f93d

Device Description

Expo model gown (length 135 cm) size XXL

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
OEA Non-Surgical Isolation Gown

GMDN Terms

Code Name
35091 Surgical gown, single-use

Identifiers

Type ID
Unit of Use 08056646507245
Primary 08056646507238