FDA UDI Not in Commercial Distribution 🇺🇸 United States

IBC Aortic Punch, Long, 4.0mm

DI: 10814321020237 · Model: APL40 · INTERNATIONAL BIOPHYSICS CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10

Basic Information

Brand Name
IBC Aortic Punch, Long, 4.0mm
Primary DI
10814321020237
Version / Model
APL40
Company Name
INTERNATIONAL BIOPHYSICS CORPORATION
Labeler DUNS
788403103
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
10
Record Status
Published
Publish Date
2016-08-02
Public Version
3
Public Version Date
2021-12-14
Public Version Status
Update
Public Device Record Key
ced36540-f41d-40ad-98f2-c4619f08403a
Distribution End Date
2021-12-13

Device Description

The IBC Aortic Punch is a single use, disposable, surgical punch to be used to create an opening(s) in the wall of the aorta to prepare a site for anastomosis.

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
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
DWS Instruments, Surgical, Cardiovascular

GMDN Terms

Code Name
47914 Aorta punch, single-use

Identifiers

Type ID
Primary 10814321020237
Unit of Use 00814321020230