Igloo Wound Irrigator 25000

GUDID 00714646000606

Wound irrigation kit

Primary Device ID	00714646000606
NIH Device Record Key	5a554fda-16a3-4e69-b225-bbbb562ff82a
Commercial Distribution Status	In Commercial Distribution
Brand Name	Igloo Wound Irrigator
Version Model Number	25000
Catalog Number	25000
Company DUNS	117844489
Company Name	Bionix, LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	true
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	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00714646000606 [Primary]

KYZ	SYRINGE, IRRIGATING (NON DENTAL)

Steralize Prior To Use	false
Device Is Sterile	true

10714646001099 - Microsuction Stater Pack	2025-07-16 Microsuction Starter Pack
10714646001105 - Microsuction Replacement Pack	2025-07-16 Microsuction Replacement Pack
10714646001129 - Sample: Opti-Tatt	2025-06-30 Opti-Tatt Sample - 2 Dot, 2 Crosshair, 2 Field Border
00714646001382 - Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement	2025-06-05 Prone Breast, Cushion, Contralateral Breast Insert, 15 degree, Replacement
00714646001399 - Prone Breast, Face Cushion, Replacement	2025-06-05 Prone Breast, Face Cushion, Replacement
00714646001405 - Prone Breast, Arm Rest, Replacement	2025-06-05 Prone Breast, Arm Rest, Replacement
00714646001412 - Prone Breast, Leg Cushion, Replacement	2025-06-05 Prone Breast, Leg Cushion, Replacement
00714646001429 - Prone Breast, Hand Post Assembly, Replacement	2025-06-05 Prone Breast, Hand Post Assembly, Replacement