FDA UDI In Commercial Distribution 🇺🇸 United States

ProCure

DI: 10840330705650 · Model: PCSL28B200 · Twin Med, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
200

Basic Information

Brand Name
ProCure
Primary DI
10840330705650
Version / Model
PCSL28B200
Catalog Number
PCSL28B200
Company Name
Twin Med, LLC
Labeler DUNS
107071289
Distribution Status
In Commercial Distribution
Device Count in Pkg
200
Record Status
Published
Publish Date
2026-04-22
Public Version
1
Public Version Date
2026-04-30
Public Version Status
New
Public Device Record Key
3f2d36c5-8de3-44f9-ae9b-95eb173c4949

Device Description

ProCure Safe Sterile Safety Lancets Button Activation 28g x 1mm (Light Blue) 200/bx 24bx/cs

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
Yes
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

GMDN Terms

Code Name
61579 Blood lancet, single-use

Identifiers

Type ID
Package 30840330705654
Primary 10840330705650
Unit of Use 00840330705653

Customer Contacts

Phone
804-776-2873

Device Sizes

Type Value Unit Text
Needle Gauge 28 Gauge
Device Size Text, specify Needle is 1 mm long