FDA.reportPublic FDA data

Batrik Non-Sterile Suture Tags Assort

Primary DI
00690521011052
Brand
Batrik Non-Sterile Suture Tags Assort
Company
Batrik Medical Manufacturing Inc
Model
911-1025
Catalog number
911-1025
Device description
"""Suture Clamp Tags, Radio Opaque, Non-Sterile, White, Assorted ø 0.06"""" x 0.5""""L"""
Published
2021-10-28
Public version status
New
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
KDCInstrument, Surgical, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690521011052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690521011052006905210110526905210110520690521011052

GMDN Terms#

Term, Definition table
TermDefinition
Operative-site suture holderA device designed to hold suture threads to facilitate their manipulation, positioning and differentiation around the operative site during a surgical procedure. It typically has a circular, oval, or curved shape with grooves or other connecting elements, and is stabilized by attachment to a surgical drape; it may also be attached to an invasive surgical retractor. 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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