LE-04-105

GUDID 10852073002255

Open-surgery electrosurgical electrode, monopolar, single-use

Primary Device ID	10852073002255
NIH Device Record Key	6e79f55e-fb74-42ff-af35-cd85f3768077
Commercial Distribution Status	In Commercial Distribution
Version Model Number	Loop Electrode
Catalog Number	LE-04-105
Company DUNS	130814890
Company Name	C R I
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00852073002258 [Primary]
GS1	10852073002255 [Package] Contains: 00852073002258 Package: Box [5 Units] In Commercial Distribution
GS1	20852073002252 [Package] Contains: 00852073002258 Package: Case [20 Units] In Commercial Distribution

HGI	Electrocautery, Gynecologic (And Accessories)

Steralize Prior To Use	false
Device Is Sterile	true

10852073002361 - NA	2020-07-02 Round Loop, Loop Size: 20mm x 13mm
10852073002378 - NA	2020-07-02 Round Loop, Loop Size: 20mm x 15mm
10852073002316 - NA	2020-06-29 Round Loop, Loop Size: 15mm x 15mm
10852073002484 - NA	2020-06-29 Round Loop, Loop Size: 15mm x 10mm
00852073002814 - NA	2020-01-21 Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based con
10852073002231 - NA	2019-05-27 Square Loop, Loop Size: 10mm x 4mm
10852073002248 - NA	2019-05-27 Round Loop, Loop Size: 5mm x 5mm
10852073002255 - NA	2019-05-27Round Loop, Loop Size: 10mm x 5mm
10852073002255 - NA	2019-05-27 Round Loop, Loop Size: 10mm x 5mm