FDA UDI In Commercial Distribution 🇺🇸 United States

American Medicals

DI: B356111PL86311ST0 · Model: 1 · American Medicals
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
American Medicals
Primary DI
B356111PL86311ST0
Version / Model
1
Company Name
American Medicals
Labeler DUNS
109909627
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-09
Public Version
2
Public Version Date
2023-09-29
Public Version Status
Update
Public Device Record Key
76df5f68-3a7b-4c41-8adc-eb2f5efa417a

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
HTE Elevator

GMDN Terms

Code Name
63947 Periosteal elevator, single-use

Identifiers

Type ID
Primary B356111PL86311ST0
Package B356111PL86311ST1