FDA UDI In Commercial Distribution 🇺🇸 United States

NA

DI: M9432001280040 · Model: 20-0128-004 · Spinal Simplicity, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
NA
Primary DI
M9432001280040
Version / Model
20-0128-004
Company Name
Spinal Simplicity, LLC
Labeler DUNS
963359513
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-07-26
Public Version
1
Public Version Date
2024-08-05
Public Version Status
New
Public Device Record Key
634a5854-a20d-46ae-891e-ffd12e2ec223

Device Description

Removal Tool

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
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
47847 Orthopaedic implant-instrument extension adaptor, reusable

Identifiers

Type ID
Primary M9432001280040