FDA UDI Not in Commercial Distribution 🇺🇸 United States

NOVO Health Services, LLC

DI: 00810019800979 · Model: 120793 · NOVO HEALTH SERVICES, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
NOVO Health Services, LLC
Primary DI
00810019800979
Version / Model
120793
Catalog Number
120793
Company Name
NOVO HEALTH SERVICES, LLC
Labeler DUNS
069936106
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-03-13
Public Version
3
Public Version Date
2023-10-27
Public Version Status
Update
Public Device Record Key
8551049e-e35a-4dd0-b776-65c15160dff7
Distribution End Date
2023-10-26

Device Description

Drape Pack, Endo NS

Device Characteristics

Single Use
No
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
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
KKX Drape, Surgical

GMDN Terms

Code Name
47780 Patient surgical drape, reusable

Identifiers

Type ID
Primary 00810019800979

Customer Contacts

Phone
8138919550

Premarket Submissions

Submission Number Supplement Number
K003755 000

Device Sizes

Type Value Unit Text
Weight 0.7 Pound
Width 5 Inch
Height 1.5 Inch