FDA UDI In Commercial Distribution 🇺🇸 United States

Intra-Lock

DI: D742RPCA50 · Model: RPCA5 · INTRA-LOCK INTERNATIONAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Intra-Lock
Primary DI
D742RPCA50
Version / Model
RPCA5
Catalog Number
RPCA5
Company Name
INTRA-LOCK INTERNATIONAL, INC.
Labeler DUNS
131500998
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-07-11
Public Version
2
Public Version Date
2019-07-30
Public Version Status
Update
Public Device Record Key
6bb9836b-5380-4a06-8ac4-284313b1c412

Device Description

Rotary Tissue Punch Contra-Angle Ø5mm

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
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
NDP Accessories, Implant, Dental, Endosseous

GMDN Terms

Code Name
55847 Dental implant system

Identifiers

Type ID
Primary D742RPCA50