FDA UDI Not in Commercial Distribution 🇺🇸 United States

PLUG T4

DI: 58032919891162 · Model: PT4R-R · HERNIAMESH SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5

Basic Information

Brand Name
PLUG T4
Primary DI
58032919891162
Version / Model
PT4R-R
Company Name
HERNIAMESH SRL
Labeler DUNS
459310140
Distribution Status
Not in Commercial Distribution
Device Count in Pkg
5
Record Status
Published
Publish Date
2018-01-08
Public Version
6
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
83cf02fd-52d1-49fe-a518-b6f00332084b
Distribution End Date
2019-03-11

Device Description

Plug T4 is a rigid pre-shaped mesh with eccentric hole knitted with Polypropylene monofilament, indicated in medium-large in direct inguinal hernias, to reduce the size of an enlarged internal ring and also reinforces the surrounding tissues.

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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
Yes
Sterilization Prior Use
No

Product Codes

Code Name
FTL Mesh, Surgical, Polymeric

GMDN Terms

Code Name
60300 Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

Identifiers

Type ID
Primary 58032919891162
Unit of Use 18032919891164