FDA UDI In Commercial Distribution 🇺🇸 United States

Stable-C

DI: B6788232500 · Model: 823250 · NEXUS SPINE, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
Stable-C
Primary DI
B6788232500
Version / Model
823250
Company Name
NEXUS SPINE, L.L.C.
Labeler DUNS
028137605
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-11-30
Public Version
2
Public Version Date
2024-08-06
Public Version Status
Update
Public Device Record Key
c1f6fadc-7a93-40f1-b74c-3e2a438ede8b

Device Description

Stable-C Implant Caddy 16x13

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
FSM Tray, Surgical, Instrument

GMDN Terms

Code Name
12143 Instrument tray, reusable

Identifiers

Type ID
Primary B6788232500
Direct Marking B678823250