FDA UDI In Commercial Distribution 🇺🇸 United States

1100 - Lumen Tray with Accessory Kit

DI: 00816634020136 · Model: 1100 · Ultra Clean Systems, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
1100 - Lumen Tray with Accessory Kit
Primary DI
00816634020136
Version / Model
1100
Company Name
Ultra Clean Systems, Inc.
Labeler DUNS
010043227
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-01-13
Public Version
3
Public Version Date
2025-05-15
Public Version Status
Update
Public Device Record Key
07fb0887-7114-4151-afba-af1cbb9ee744

Device Description

Model 1100 - Lumen Tray with Accessory Kit

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
Yes
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
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
FLG Cleaner, Ultrasonic, Medical Instrument

GMDN Terms

Code Name
36749 Ultrasonic-cleaning water bath

Identifiers

Type ID
Primary 00816634020136