Tube set for irrigation, single-use

GUDID 04056702008864

W.O.M. World of Medicine GmbH

Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use Surgical irrigation tubing set, single-use

Primary Device ID	04056702008864
NIH Device Record Key	313b009d-e91b-43a1-aba1-70a737af9172
Commercial Distribution Status	In Commercial Distribution
Brand Name	Tube set for irrigation, single-use
Version Model Number	INFLWTBING
Company DUNS	316305242
Company Name	W.O.M. World of Medicine GmbH
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	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04056702008857 [Primary]
GS1	04056702008864 [Package] Contains: 04056702008857 Package: [10 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173489

FDA Product Code

HIG	Insufflator, Hysteroscopic

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-11-09
Device Publish Date	2020-11-01

On-Brand Devices [Tube set for irrigation, single-use]

04056702005382	T0505-01
04056702002770	VP150-10
04056702002367	4170.224
04056702002329	4170.223
04056702002152	AQL-110
04056702001629	WA40635A
04056702000769	Z1424-01
04056702000097	Z0449-01
04056702008864	INFLWTBING