FDA.report

Batrik In-Brush Twisted Wire Brushes

Primary DI
00690521005686
Brand
Batrik In-Brush Twisted Wire Brushes
Company
Batrik Medical Manufacturing Inc
Model
22-12236
Catalog number
22-12236
Device description
Brush\BD-6.00mm\BL-76mm\OL-305mm - Nylon Twisted Wire
Published
2020-09-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
MNLAccessories, Cleaning Brushes, For Endoscope

Product Code Classifications

CodeDeviceSpecialtyClass
MNLAccessories, Cleaning Brushes, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00690521005686PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521005686006905210056866905210056860690521005686

GMDN Terms

TermDefinition
Surgical instrument/endoscope cleaning brush/tool, reusableA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient temperature

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
514-631-7988info@surgmed.com

Regulatory Flags

DUNS number
243880700
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

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00690521022683Batrik ShoozCovers™ SC-2112-NPBSC-2112-NPB2025-02-14
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00690521022881Batrik ShoozCovers™ SC-1220-PBSC-1220-PB2025-02-14

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