FDA UDI In Commercial Distribution 🇺🇸 United States

Trulife

DI: 00645517898766 · Model: PSK01 · TRULIFE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Trulife
Primary DI
00645517898766
Version / Model
PSK01
Company Name
TRULIFE LIMITED
Labeler DUNS
289728891
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-09-11
Public Version
1
Public Version Date
2025-09-19
Public Version Status
New
Public Device Record Key
a4eff18d-1e32-4d08-89f0-54ceeeb6a0d7

Device Description

PECTUS PRO PAD/STRAP KIT

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
No

Product Codes

Code Name
MRI Orthosis, Truncal/Orthosis, Limb

GMDN Terms

Code Name
41042 Thoracic spine orthosis

Identifiers

Type ID
Primary 00645517898766