FDA UDI In Commercial Distribution 🇺🇸 United States

Straight guide Ø2 x 820 mm

DI: 07640187911343 · Model: T602 · MPS Micro Precision Systems AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Straight guide Ø2 x 820 mm
Primary DI
07640187911343
Version / Model
T602
Catalog Number
T602
Company Name
MPS Micro Precision Systems AG
Labeler DUNS
482204059
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-08-26
Public Version
3
Public Version Date
2023-09-18
Public Version Status
Update
Public Device Record Key
87bf49be-cbec-4efc-b511-286c63950bb4

Device Description

The straight guide is used to lead intramedullary reamer in its proper course into the medullary canal. The end piece permits to prevent and retain the intramedullary reamer in case of sliding along the guide. The length varies from 440 to 820 mm and the diameter from 2 to 3 mm. Two kind of head, permitting to maintain the intramedullary reamer, exist. This is a reusable device.

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

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
FZX Guide, Surgical, Instrument

GMDN Terms

Code Name
46165 Orthopaedic guidewire, reusable

Identifiers

Type ID
Primary 07640187911343

Customer Contacts

Phone
999-999-9999