FDA UDI In Commercial Distribution 🇺🇸 United States

Osteotec Silicone Finger - Osteotec All In One Silicone Finger Set

DI: 05060183095588 · Model: OSTF-INS9 · OSTEOTEC LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Osteotec Silicone Finger - Osteotec All In One Silicone Finger Set
Primary DI
05060183095588
Version / Model
OSTF-INS9
Catalog Number
OSTF-INS9
Company Name
OSTEOTEC LIMITED
Labeler DUNS
348489386
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-01-03
Public Version
1
Public Version Date
2024-01-11
Public Version Status
New
Public Device Record Key
846c6272-e38a-4a99-a26a-413ce6cce9b2

Device Description

Tray of Osteotec Silicone Finger Sizers and Instruments

Device Characteristics

Single Use
No
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
No
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
OJH Orthopedic Tray

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 05060183095588