FDA UDI In Commercial Distribution 🇺🇸 United States

Surgery-Tray PROGRESSIVE-LINE Flex

DI: E219J530089201 · Model: J5300.8920 · ALTATEC GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Surgery-Tray PROGRESSIVE-LINE Flex
Primary DI
E219J530089201
Version / Model
J5300.8920
Catalog Number
J5300.8920
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
24855bed-705c-40d9-a31c-0a3f2de58680

Device Description

Surgery-Tray PROGRESSIVE-LINE Flex

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 E219J530089201
Direct Marking E219J530089200

Customer Contacts

Phone
7609181857