FDA.reportPublic FDA data

Batrik First Check Scope Bag 30.5"

Primary DI
00690521016149
Brand
Batrik First Check Scope Bag 30.5"
Company
Batrik Medical Manufacturing Inc
Model
17-HAP30
Catalog number
17-HAP30
Device description
Transport Bags fo Endoscope & Medical Instruments (Clean Instruments Bags), 30.5"x 26"
Published
2021-12-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690521016149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521016149006905210161496905210161490690521016149

GMDN Terms#

Term, Definition table
TermDefinition
Instrument hygienic-transportation bagA non-sterile flexible plastic container intended to collect and contain an instrument(s) [e.g., an endoscope] following an invasive procedure, for hygienic transportation of the device to a reprocessing facility. It is typically a drawstring bag/wrap which may be designed to be laid flat on the procedure tray/trolley during the procedure and then closed to contain the device; it is not a drape/cover. 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
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00690521025332EcoZyme First Touch19560-TS-BAG19560-TS-BAG2025-07-10
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
00690521020986Batrik ShoozCovers™ SC-1216-PBSC-1216-PB2025-02-14
00690521021365Batrik ShoozCovers™ SC-1226-PBSC-1226-PB2025-02-14
00690521021396Batrik ShoozCovers™ SC-1616-PBSC-1616-PB2025-02-14
00690521021419Batrik ShoozCovers™ SC-1922-PDBSC-1922-PDB2025-02-14
00690521021426Batrik ShoozCovers™ SC-1922-PBSC-1922-PB2025-02-14
00690521022683Batrik ShoozCovers™ SC-2112-NPBSC-2112-NPB2025-02-14
00690521022690Batrik ShoozCovers™ SC-2122-NPBSC-2122-NPB2025-02-14
00690521022881Batrik ShoozCovers™ SC-1220-PBSC-1220-PB2025-02-14

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