FDA UDI In Commercial Distribution 🇺🇸 United States

SUMMIT

DI: 00817650022708 · Model: SL350 · Harmar Summit, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
SUMMIT
Primary DI
00817650022708
Version / Model
SL350
Catalog Number
17161-W
Company Name
Harmar Summit, LLC
Labeler DUNS
144008062
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-09-28
Public Version
4
Public Version Date
2023-04-19
Public Version Status
Update
Public Device Record Key
d959fd86-5f89-4cb1-8a63-29cfa313754c

Device Description

ASSY,CHASSIS,AC,90VDC-WARRANT

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
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ILK Transport, patient, powered

GMDN Terms

Code Name
30038 Stairlift, chair

Identifiers

Type ID
Primary 00817650022708

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K032880 000