FDA UDI In Commercial Distribution 🇺🇸 United States

2 PACK OT EQUATOR IMPRESSION COPING

DI: D785OTPU20 · Model: OT PU 2 · OCO BIOMEDICAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
2 PACK OT EQUATOR IMPRESSION COPING
Primary DI
D785OTPU20
Version / Model
OT PU 2
Catalog Number
OT PU 2
Company Name
OCO BIOMEDICAL INC
Labeler DUNS
094146123
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-02-04
Public Version
1
Public Version Date
2026-02-12
Public Version Status
New
Public Device Record Key
92dc2787-7be1-4c91-a97d-fdfb7d51feab

Device Description

2 PACK OT EQUATOR IMPRESSION COPING

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
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
No

Product Codes

Code Name
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
38625 Denture clasp, polymer, preformed

Identifiers

Type ID
Primary D785OTPU20