FDA UDI In Commercial Distribution 🇺🇸 United States

RX Locking Device and Biopsy Cap

DI: 08714729746676 · Model: M00545260 · BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
RX Locking Device and Biopsy Cap
Primary DI
08714729746676
Version / Model
M00545260
Company Name
BOSTON SCIENTIFIC CORPORATION
Labeler DUNS
021717889
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-24
Public Version
4
Public Version Date
2023-03-14
Public Version Status
Update
Public Device Record Key
f37b3e90-a243-4ac0-9cb4-a5b4b6235732

Device Description

Locking Device and Biopsy Cap For Use with RX Biliary System

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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
ODC Endoscope channel accessory

GMDN Terms

Code Name
62145 Endoscopic biopsy valve, single-use

Identifiers

Type ID
Package 08714729296614
Primary 08714729746676