FDA.reportPublic FDA data

Batrik Skins

Primary DI
00690521002821
Brand
Batrik Skins
Company
Batrik Medical Manufacturing Inc
Model
S-3001
Catalog number
S-3001
Device description
Surgical Skin Markers, Multi-Tip fine Marker, Sterile
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
true
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZZMarker, Skin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZZMarker, SkinGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690521002821PackageGS150In Commercial Distribution
00690521014923PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521002821006905210028216905210028210690521002821
00690521014923006905210149236905210149230690521014923

GMDN Terms#

Term, Definition table
TermDefinition
Skin marking pen, single-useA dedicated pen intended to be used to delineate areas on the skin surface of a patient (e.g., to outline surgical incision sites, for dermatology applications) utilizing non-toxic ink. It is typically a felt-tip pen which may include a sterile disposable ruler. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and at ambient temperature

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
514-631-7988ifo@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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
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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Primary DI, Brand, Company table
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16931918101040AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918108414AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918152356AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
16931918161327AllesetGRI Medical & Electronic Technology Co., Ltd.FZZ2026-02-09
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