FDA UDI In Commercial Distribution 🇺🇸 United States

Aquamantys ®

DI: 00643169078611 · Model: 23-301-1 · MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Aquamantys ®
Primary DI
00643169078611
Version / Model
23-301-1
Company Name
MEDTRONIC, INC.
Labeler DUNS
030200852
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-04-16
Public Version
2
Public Version Date
2018-03-29
Public Version Status
Update
Public Device Record Key
dd9c8365-06ef-4b93-8863-f6e346fa47de

Device Description

BIPOLAR SEALER 23-301-1 AQM MBS W/LIGHT

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
No
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
GEI ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

GMDN Terms

Code Name
56296 Open-surgery electrosurgical handpiece/electrode, bipolar, single-use

Identifiers

Type ID
Primary 00643169078611

Customer Contacts

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
50 – 104 Degrees Fahrenheit
Type
Storage Environment Humidity
Temperature Range
15 – 85 Percent (%) Relative Humidity