FDA UDI In Commercial Distribution 🇺🇸 United States

De Mayo Ankle Distractor™

DI: 00696588005348 · Model: 1109-XS KIT DEMO · Innovative Medical Products, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
De Mayo Ankle Distractor™
Primary DI
00696588005348
Version / Model
1109-XS KIT DEMO
Catalog Number
1109-XS KIT DEMO
Company Name
Innovative Medical Products, Inc
Labeler DUNS
147363154
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-11-08
Public Version
1
Public Version Date
2019-11-18
Public Version Status
New
Public Device Record Key
c4e96043-1c85-4cea-8b42-a38936625c30

Device Description

Demo De Mayo Ankle Distractor™ Sterilization Cases (1 each of 1109-XS and 1109-S)

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
Yes
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
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
FWZ Operating Room Accessories Table Tray

GMDN Terms

Code Name
62787 Orthopaedic surgical distractor, external

Identifiers

Type ID
Primary 00696588005348