FDA UDI Not in Commercial Distribution 🇺🇸 United States

Zimmer

DI: 00843059118681 · Model: ZS-0521 · TEDAN SURGICAL INNOVATIONS, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Zimmer
Primary DI
00843059118681
Version / Model
ZS-0521
Company Name
TEDAN SURGICAL INNOVATIONS, L.L.C.
Labeler DUNS
791619393
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-12-25
Public Version
5
Public Version Date
2023-09-28
Public Version Status
Update
Public Device Record Key
77937ec0-ac68-452a-881a-59e9915f78a6
Distribution End Date
2023-09-27

Device Description

LATERAL BLADES SECTIONAL 18MM X 100MM

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
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
MDM Instrument, Manual, Surgical, General Use

GMDN Terms

Code Name
46774 Surgical retractor/retraction system blade, reusable

Identifiers

Type ID
Primary 00843059118681