FDA UDI In Commercial Distribution 🇺🇸 United States

American Medicals

DI: B35675440000 · Model: 1 · American Medicals
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
American Medicals
Primary DI
B35675440000
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
2022-09-08
Public Version
2
Public Version Date
2023-01-20
Public Version Status
Update
Public Device Record Key
55bf2b03-17ab-4526-8baa-77accf7572ae

Device Characteristics

Single Use
No
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
No
Sterilization Prior Use
Yes
Sterilization Methods
Microwave Radiation

Product Codes

Code Name
GAF Spatula, Surgical, General & Plastic Surgery

GMDN Terms

Code Name
64971 General surgery wound probe/packer

Identifiers

Type ID
Primary B35675440000