FDA UDI In Commercial Distribution 🇺🇸 United States

TRU-LOOP

DI: 00812444022803 · Model: CM-0204 · RIVERPOINT MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
5
Pkg Device Count
1

Basic Information

Brand Name
TRU-LOOP
Primary DI
00812444022803
Version / Model
CM-0204
Company Name
RIVERPOINT MEDICAL, LLC
Labeler DUNS
964053560
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2015-10-24
Public Version
6
Public Version Date
2023-06-02
Public Version Status
Update
Public Device Record Key
89b193e3-6c74-4cd9-bd58-8c8f0679d39d

Device Description

SUTURE

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
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
GAT Suture, Nonabsorbable, Synthetic, Polyethylene

GMDN Terms

Code Name
13907 Polyolefin/fluoropolymer suture, multifilament

Identifiers

Type ID
Package 10812444022800
Primary 00812444022803
Package 20812444022807
Package 10812444025108
Package 30812444022804