FDA UDI In Commercial Distribution 🇺🇸 United States

Lightning

DI: 00811714036120 · Model: 905005-0001-P01 · RESPONSIVE ORTHOPEDICS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Lightning
Primary DI
00811714036120
Version / Model
905005-0001-P01
Catalog Number
905005-0001-P01
Company Name
RESPONSIVE ORTHOPEDICS LLC
Labeler DUNS
002745858
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2024-05-20
Public Version
1
Public Version Date
2024-05-28
Public Version Status
New
Public Device Record Key
6d860e42-939d-4768-8a3a-52cd01ff8922

Device Description

Lightning Blunt Probe

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
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
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
35948 Endoscopic surgical probe

Identifiers

Type ID
Primary 00811714036120