FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: 04251339900042 · Model: STEA-OT4 · MAVIG GmbH
Product Codes
2
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
NA
Primary DI
04251339900042
Version / Model
STEA-OT4
Catalog Number
STEA-OT4
Company Name
MAVIG GmbH
Labeler DUNS
317502326
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-07-05
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
c634ee57-a440-44d1-8457-23dd9636cb9c

Device Description

Sterile disposable cover for OT54001/OT94001, 90 x 120 cm (1 pouch)

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
No
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
MMP Cover, Barrier, Protective
KKX Drape, Surgical

GMDN Terms

Code Name
45021 Instrument/equipment drape, single-use, sterile

Identifiers

Type ID
Package 04251339900035
Primary 04251339900042