FDA UDI In Commercial Distribution 🇺🇸 United States

Ulna Osteotomy Plate, 6-Hole

DI: 09120069811629 · Model: 21231-6 · I.T.S. GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Ulna Osteotomy Plate, 6-Hole
Primary DI
09120069811629
Version / Model
21231-6
Catalog Number
21231-6
Company Name
I.T.S. GmbH
Labeler DUNS
303456917
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-09-03
Public Version
6
Public Version Date
2025-11-20
Public Version Status
Update
Public Device Record Key
8f47329e-19ba-4d1c-88f5-878c2200f126

Device Description

Ulna Osteotomy Plate, 6-Hole

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
Yes
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
HRS Plate, Fixation, Bone

GMDN Terms

Code Name
46647 Orthopaedic fixation plate, non-bioabsorbable

Identifiers

Type ID
Primary 09120069811629