FDA UDI In Commercial Distribution 🇺🇸 United States

DeRoyal

DI: 00749756376402 · Model: 89-10765 · DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
DeRoyal
Primary DI
00749756376402
Version / Model
89-10765
Catalog Number
89-10765
Company Name
DEROYAL INDUSTRIES, INC.
Labeler DUNS
096372255
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-02-03
Public Version
1
Public Version Date
2023-02-13
Public Version Status
New
Public Device Record Key
dfa98048-502d-4e27-9a96-de3dbd115fde

Device Description

TOTAL KNEE PACK

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
LRO General surgery tray

GMDN Terms

Code Name
33961 General surgical procedure kit, non-medicated, single-use

Identifiers

Type ID
Package 50749756376407
Primary 00749756376402