FDA UDI In Commercial Distribution 🇺🇸 United States

Unistik TinyTouch

DI: 00384701260018 · Model: AT 1260 · OWEN MUMFORD USA INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
25

Basic Information

Brand Name
Unistik TinyTouch
Primary DI
00384701260018
Version / Model
AT 1260
Company Name
OWEN MUMFORD USA INCORPORATED
Labeler DUNS
803401454
Distribution Status
In Commercial Distribution
Device Count in Pkg
25
Record Status
Published
Publish Date
2023-03-22
Public Version
1
Public Version Date
2023-03-30
Public Version Status
New
Public Device Record Key
d4580bb9-f978-4fc8-9204-a387a311950e

Device Description

Unistik TinyTouch Full Term individually packaged in a carton, 1.0mm x 2.50mm

Device Characteristics

Single Use
Yes
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
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
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
61578 Manual blood lancing device, single-use

Identifiers

Type ID
Package 00384701260032
Primary 00384701260018
Unit of Use 00384701250002