FDA UDI In Commercial Distribution 🇺🇸 United States

Sterling Medical Products

DI: 00685404002098 · Model: BC-033 · APOLLO MEDICAL PRODUCTS CORP.
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Sterling Medical Products
Primary DI
00685404002098
Version / Model
BC-033
Company Name
APOLLO MEDICAL PRODUCTS CORP.
Labeler DUNS
116768422
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-02-04
Public Version
1
Public Version Date
2020-02-12
Public Version Status
New
Public Device Record Key
7225c8fb-dc4f-4d3b-8e8b-1591ebeca698

Device Description

Ultrasound Biopsy Kit

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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

GMDN Terms

Code Name
16835 Soft-tissue biopsy procedure kit, non-medicated

Identifiers

Type ID
Package 10685404002095
Primary 00685404002098

Customer Contacts

Phone
815-537-5303