FDA.reportPublic FDA data

Batrik Couvrette Valve Covers - Pink

Primary DI
00690521015845
Brand
Batrik Couvrette Valve Covers - Pink
Company
Batrik Medical Manufacturing Inc
Model
16-0044
Catalog number
16-0044
Device description
Biopsy Valve Cover - Pentax - Pink
Published
2021-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FFYAdaptor, Bulbs, Miscellaneous, For Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFYAdaptor, Bulbs, Miscellaneous, For EndoscopeGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690521015845PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521015845006905210158456905210158450690521015845

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic biopsy valve, single-useA device intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure. It is typically in the form of a small attachment with an elastomer seal; it may include features to allow for simultaneous irrigation/biopsy, or to allow suction via the biopsy port. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep Dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
514-631-7988info@surgmed.com

Regulatory Flags#

DUNS number
243880700
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00690521025196EcoZyme First Touch19560-TS19560-TS2025-07-11
00690521025226EcoZyme First Touch19560-FS19560-FS2025-07-11
00690521025257EcoZyme First Touch19560-TS50019560-TS5002025-07-11
00690521025271EcoZyme First Touch19560-TS22019560-TS2202025-07-11
00690521025295EcoZyme First Touch19560-FS50019560-FS5002025-07-11
00690521025318EcoZyme First Touch19560-FS22019560-FS2202025-07-11
00690521025332EcoZyme First Touch19560-TS-BAG19560-TS-BAG2025-07-10
00690521015012Batrik Your First Check17-22217-2222025-07-11
00690521015876Batrik Your First Check17-22217-2222025-07-11
00690521025202EcoZyme First Touch19560-TS19560-TS2025-07-11
00690521025233EcoZyme First Touch19560-FS19560-FS2025-07-11
00690521025264EcoZyme First Touch19560-TS50019560-TS5002025-07-11
00690521025288EcoZyme First Touch19560-TS22019560-TS2202025-07-11
00690521025301EcoZyme First Touch19560-FS50019560-FS5002025-07-11
00690521025325EcoZyme First Touch19560-FS22019560-FS2202025-07-11
00690521014855Batrik Your First Check Cylindrical Sponge w/Enz. Sol17-11117-111, 19560-TS-BAG2022-01-27
00690521019201Batrik ShoozCovers™ SC-1216-PDBSC-1216-PDB2025-02-14
00690521019218Batrik ShoozCovers™ SC-1226-PDBSC-1226-PDB2025-02-14
00690521020948Batrik ShoozCovers™ SC-1210-PBSC-1210-PB2025-02-14
00690521020955Batrik ShoozCovers™ SC-1616-PDBSC-1616-PDB2025-02-14

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