FDA.reportPublic FDA data

Batrik Instrument Protectors

Primary DI
00690521001978
Brand
Batrik Instrument Protectors
Company
Batrik Medical Manufacturing Inc
Model
PT-03
Catalog number
PT-03
Device description
Instrument Protectors, Perforated, Tinted Green, 0.109" x 0.75" (2.77 mm x 19 mm)
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690521001978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521001978006905210019786905210019780690521001978

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-use, non-sterileA non-sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at ambient temperature and away from direct sunlight

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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06438394020382Activa InstrumentBioretec OyMDM2026-03-23
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