FDA.report

Batrik Arc Wire Brushes Single Use

Primary DI
00690521008366
Brand
Batrik Arc Wire Brushes Single Use
Company
Batrik Medical Manufacturing Inc
Model
41-46502-S
Catalog number
41-46502-S
Device description
Brush/White/BD 2mm/BL 15mm/OL 45cm - Flexible - SINGLE USE
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
true

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
00690521008366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521008366006905210083666905210083660690521008366

GMDN Terms

TermDefinition
Surgical instrument/endoscope cleaning brush/tool, single-useA 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 single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient temperature

Sterilization Methods

Method

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
false

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00690521025264EcoZyme First Touch19560-TS50019560-TS5002025-07-11
00690521025288EcoZyme First Touch19560-TS22019560-TS2202025-07-11
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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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