FDA UDI In Commercial Distribution 🇺🇸 United States

ENDOSKELETON® TAS

DI: 00191375032090 · Model: 11-01445-00 · MEDTRONIC SOFAMOR DANEK, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ENDOSKELETON® TAS
Primary DI
00191375032090
Version / Model
11-01445-00
Company Name
MEDTRONIC SOFAMOR DANEK, INC.
Labeler DUNS
830350380
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2019-11-01
Public Version
7
Public Version Date
2022-09-16
Public Version Status
Update
Public Device Record Key
39ef2fd0-da54-48c8-8287-8d50776c2888

Device Description

Perforated Inner Tray, Upper

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
No
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
LRP TRAY, SURGICAL

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary 00191375032090

Customer Contacts

Device Sizes

Type Value Unit Text
Height 2 Inch
Width 10 Inch
Device Size Text, specify TAS Implant, Rigid Tray System, Inner Tray
Device Size Text, specify Top Tray
Length 21 Inch