FDA.reportPublic FDA data

Biotronix Healthcare Suture Removal Tray

Primary DI
00850005165293
Brand
Biotronix Healthcare Suture Removal Tray
Company
BIOTRONIX HEALTHCARE INDUSTRIES, INC.
Model
OR4001
Catalog number
OR4001
Device description
Suture Removal Tray
Published
2021-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDDKit, Surgical Instrument, Disposable
MCZSuture Removal Kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDDKit, Surgical Instrument, DisposableGeneral, Plastic Surgery1
MCZSuture Removal KitGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005165290PackageGS150In Commercial Distribution
00850005165293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000516529010850005165290
00850005165293008500051652938500051652930850005165293

GMDN Terms#

Term, Definition table
TermDefinition
Suture removal kitA collection of various sterile instruments, dressings, and pharmaceuticals designed to remove sutures from a patient. It typically includes a disinfectant, scissors, forceps, gauze and bandages. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Contacts#

Phone, Email table
PhoneEmail
786-473-9436sales@biotronixhealthcare.com

Regulatory Flags#

DUNS number
065762392
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
00850005165576Biotroix Healthcare SyringesGE12010SGE12010S2024-03-11
00850005165798Biotronix Healthcare SyringesGE12035GE120352019-10-18
00858835007202Biotronix HealthCare SyringesGE12012GE120122019-10-10
00858835007219Biotronix HealthCare SyringesGE12010GE120102019-10-10
00858835007226Biotronix Healthcare SyringesGE12033GE120332019-10-10
00858835007233Biotronix Healthcare SyringesGE12034GE120342019-10-12
00858835007240Biotronix Healthcare SyringesGE12030GE120302019-10-12
00858835007257Biotronix Healthcare SyringesGE12032GE120322019-10-12
00858835007264Biotronix Healthcare SyringesGE12029GE120292019-10-12
00858835007271Biotronix Healthcare SyringesGE12047GE120472019-10-12
00858835007288Biotronix Healthcare SyringesGE12055GE120552019-10-12
00858835007295Biotronix Healthcare SyringesGE12053GE120532019-10-12
00858835007318Biotronix Healthcare SyringesGE12023GE120232019-10-12
00858835007332Biotronix Healthcare SyringesGE12025GE120252019-10-12
00858835007349Biotronix Healthcare SyringesE12026GE120262019-10-12
00858835007356Biotronix Healthcare SyringesGE12027GE120272019-10-12
00858835007783Biotronix Healthcare SyringesGE12026GE120262019-10-12
00864085000405Biotronix Healthcare SyringesGE12085GE120852019-10-13
00864085000412Biotronix Healthcare SyringesGE12041GE120412019-10-13
00858835007004Biotronix HealthcareGE36419GE364192019-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800071700500TIGER GUARD PLUSKims Med Co.,Ltd.KDD2025-11-28
10080196042777MEDLINEMEDLINE INDUSTRIES, INC.KDD2025-06-02
08800071700111Tiger GuardKims Med Co.,Ltd.KDD2024-07-30
10193489951936Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2024-07-29
08906039319729OSSEOUS Myringotomy Kit-StandardEON MEDITECH PRIVATE LIMITEDKDD2024-07-04
08906039319736OSSEOUS Myringotomy Kit-Pediatric EON MEDITECH PRIVATE LIMITEDKDD2024-07-04
10192253065442Aero-MedAERO-MED, LLCKDD2024-03-11
00811870037979Manus Medical, LLCManus Medical, LLCKDD2024-02-06
10193489447897Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2023-06-08
10195327242763Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-11-23
10195327244835Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-11-23
10080196813841MedlineMEDLINE INDUSTRIES, INC.KDD2022-11-08
10195327239350Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-09-04
10195327239480Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-09-04
10195327227289Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327227852Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327228842Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327229238Medline Industries, Inc.MEDLINE INDUSTRIES, INC.MCZ2022-08-28
10195327230067Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327230203Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327230609Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327230777Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327232610Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327233419Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327233426Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327233440Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327234010Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-28
10195327221010Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-14
10195327221454Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-14
10195327221829Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KDD2022-08-14