FDA.report

DEFENDO

Primary DI
10724995229648
Brand
DEFENDO
Company
MEDIVATORS INC.
Model
4008055
Catalog number
4008055
Device description
Defendo Cleaning Adapter Non-Sterile
Published
2024-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
ODCEndoscope channel accessory

Product Code Classifications

CodeDeviceSpecialtyClass
ODCEndoscope Channel AccessoryGastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K240352000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240352000Defendo Single Use Cleaning Adapter for Olympus EndoscopesSTERIS Corporation2024-03-06ODC

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10724995229648PackageGS150In Commercial Distribution
00724995229641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499522964810724995229648
00724995229641007249952296417249952296410724995229641

GMDN Terms

TermDefinition
Surgical irrigation tubing set, single-useA collection of flexible, noninvasive, single-lumen tubing and associated items intended to provide a conduit to deliver a sterile irrigation solution (e.g., saline) from its source (e.g., gravity feed bag, feed pump) to a surgical cannula (not included) during a surgical procedure (endoscopy, laparoscopy); it is not intended to navigate through an anatomical lumen. The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)444-4729custserv@MEDIVATORS.com

Regulatory Flags

DUNS number
068199363
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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