FDA UDI In Commercial Distribution 🇺🇸 United States

JAZZ System

DI: 03607505500577 · Model: Forceps · IMPLANET
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
JAZZ System
Primary DI
03607505500577
Version / Model
Forceps
Catalog Number
550057
Company Name
IMPLANET
Labeler DUNS
291993439
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2017-05-18
Public Version
6
Public Version Date
2019-09-26
Public Version Status
Update
Public Device Record Key
23a196d7-3d25-4644-96cb-e312cfd19ea6

Device Description

Forceps

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
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
OWI Bone Fixation Cerclage, Sublaminar

GMDN Terms

Code Name
42894 Implant handling forceps, scissors-like

Identifiers

Type ID
Primary 03607505500577

Premarket Submissions

Submission Number Supplement Number
K160226 000
K170730 000
K171881 000
K182771 000
K191217 000