Model: IRIS Thermocoagulator and Digital Colposcope Unit
DI: 00860005151004
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
IRIS Thermocoagulator and Digital Colposcope
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
9dd718c2-a7d7-4d27-8a6b-9260f9be459e
Distribution Status:
In Commercial Distribution
DUNS Number:
035280324
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00860005151004
Type:
Primary
Issuing Agency:
GS1
GMDN
Code:
Name:
FDA Product Codes
HGI
Electrocautery, Gynecologic (And Accessories)
PTZ
Colposcope (And Colpomicroscope), Exempt
Premarket Submissions
Submission Number:
K202915
Supplement Number:
000