FDA UDI In Commercial Distribution 🇺🇸 United States

N/A

DI: 00643169078550 · Model: 13-101-1 · MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
N/A
Primary DI
00643169078550
Version / Model
13-101-1
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
3
Public Version Date
2019-02-07
Public Version Status
Update
Public Device Record Key
33200606-1a65-4e41-8870-6a073890e47f

Device Description

MONO SEALER 13-101-1 DISSECTING DS3.0

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
61869 Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Identifiers

Type ID
Primary 00643169078550

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