FDA UDI In Commercial Distribution 🇺🇸 United States

golden gate™ anterior plate system

DI: 04052536019281 · Model: CS 3608-045 · Ulrich GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
golden gate™ anterior plate system
Primary DI
04052536019281
Version / Model
CS 3608-045
Catalog Number
CS 3608-045
Company Name
Ulrich GmbH & Co. KG
Labeler DUNS
315494757
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2016-07-30
Public Version
4
Public Version Date
2023-09-18
Public Version Status
Update
Public Device Record Key
d5dbde3a-b4e5-482b-88b0-5576ba95199e

Device Description

golden gate screw, length 45 mm cannulated

Device Characteristics

Single Use
Yes
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
MR Conditional
Direct Marking Exempt
No
PM Exempt
No
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
KWQ APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

GMDN Terms

Code Name
46653 Spinal fixation plate, non-bioabsorbable

Identifiers

Type ID
Primary 04052536019281

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K101353 000