FDA UDI In Commercial Distribution 🇺🇸 United States

TRAY COVER QUATERA 700

DI: 04049539104731 · Model: 303061-9112-000 · Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
TRAY COVER QUATERA 700
Primary DI
04049539104731
Version / Model
303061-9112-000
Company Name
Carl Zeiss Meditec AG
Labeler DUNS
342228620
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-04-25
Public Version
1
Public Version Date
2022-05-03
Public Version Status
New
Public Device Record Key
d77c2115-b19f-49c4-a96c-54c8460711ec

Device Description

The products are single use, sterile drapes to cover all surfaces of the main device with a potential need to get in contact with sterile objects during surgical procedures.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
PUI Drape, Surgical, Exempt

GMDN Terms

Code Name
12535 Medical equipment drape, single-use

Identifiers

Type ID
Package 04049539104748
Primary 04049539104731