FDA UDI Not in Commercial Distribution 🇺🇸 United States

TRYPTIK 2 C-PLATE INSTRUMENTATION

DI: 07640151108021 · Model: TRY-IN 18 00-N · SpineArt SA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
TRYPTIK 2 C-PLATE INSTRUMENTATION
Primary DI
07640151108021
Version / Model
TRY-IN 18 00-N
Catalog Number
TRY-IN 18 00-N
Company Name
SpineArt SA
Labeler DUNS
483016148
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-08-03
Public Version
4
Public Version Date
2021-04-21
Public Version Status
Update
Public Device Record Key
9597052f-14f5-4373-a7e3-2fa503709d6f
Distribution End Date
2019-02-06

Device Description

Bayoneted Plate Holder

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
No
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
KWQ Appliance, Fixation, Spinal Intervertebral Body

GMDN Terms

Code Name
47807 Surgical implant/trial-implant/sizer holder, reusable

Identifiers

Type ID
Primary 07640151108021