FDA UDI Not in Commercial Distribution 🇺🇸 United States

XPS® Straightshot®

DI: 00681490693950 · Model: 1897201 · MEDTRONIC XOMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
XPS® Straightshot®
Primary DI
00681490693950
Version / Model
1897201
Company Name
MEDTRONIC XOMED, INC.
Labeler DUNS
835465063
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-05-05
Public Version
5
Public Version Date
2019-02-19
Public Version Status
Update
Public Device Record Key
405ecdd3-64f5-4a6c-94b7-40022076ce36
Distribution End Date
2018-10-24

Device Description

HANDPIECE 1897201 STRAIGHTSHOT III

Device Characteristics

Single Use
No
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
Yes
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
["Ethylene Oxide", "Moist Heat or Steam Sterilization"]

Product Codes

Code Name
MUU System, suction, lipoplasty

GMDN Terms

Code Name
44491 Multi-purpose surgical power tool system, line-powered

Identifiers

Type ID
Primary 00681490693950

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K992855 000