FDA UDI In Commercial Distribution 🇺🇸 United States

Guide Surgery-Tray PROGRESSIVE-LINE

DI: E219J530089191 · Model: J5300.8919 · ALTATEC GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Guide Surgery-Tray PROGRESSIVE-LINE
Primary DI
E219J530089191
Version / Model
J5300.8919
Catalog Number
J5300.8919
Company Name
ALTATEC GmbH
Labeler DUNS
322018193
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-10-14
Public Version
5
Public Version Date
2022-12-06
Public Version Status
Update
Public Device Record Key
0a29ad54-aa4b-4cac-a7cd-250f1e9ad98e

Device Description

Guide Surgery-Tray PROGRESSIVE-LINE

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
FSM Tray, Surgical, Instrument

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary E219J530089191
Direct Marking E219J902000210

Customer Contacts

Phone
7609181857