FDA UDI In Commercial Distribution 🇺🇸 United States

Coonrad/Morrey Total Elbow

DI: 00889024701946 · Model: 32-8105-25-01 · Zimmer, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Coonrad/Morrey Total Elbow
Primary DI
00889024701946
Version / Model
32-8105-25-01
Catalog Number
32-8105-025-01
Company Name
Zimmer, Inc.
Labeler DUNS
056038268
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-10-09
Public Version
1
Public Version Date
2025-10-17
Public Version Status
New
Public Device Record Key
36f43d05-7f04-47c3-beae-b410900d98f1

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
MR Conditional
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
JDC PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

GMDN Terms

Code Name
40124 Hinged total elbow prosthesis

Identifiers

Type ID
Primary 00889024701946

Premarket Submissions

Submission Number Supplement Number
K001989 000
K181307 000