FDA UDI In Commercial Distribution 🇺🇸 United States

n/a

DI: 00822409054220 · Model: 264-0007-35 · Ortho Development Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
n/a
Primary DI
00822409054220
Version / Model
264-0007-35
Company Name
Ortho Development Corporation
Labeler DUNS
876542390
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-10
Public Version
2
Public Version Date
2023-05-03
Public Version Status
Update
Public Device Record Key
b1dd6899-1fff-45b7-9b42-019d0a3c7bce

Device Description

Patella Cementing Clamp Head 35mm

Device Characteristics

Single Use
No
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
Yes
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
LXH ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

GMDN Terms

Code Name
47847 Orthopaedic implant-instrument extension adaptor, reusable

Identifiers

Type ID
Primary 00822409054220

Customer Contacts

Device Sizes

Type Value Unit Text
Outer Diameter 35 Millimeter