FDA.reportPublic FDA data

Anzen Safety Scalpel

Primary DI
38886354702639
Brand
Anzen Safety Scalpel
Company
MEDIPURPOSE PTE. LTD.
Model
AZH3L
Device description
Anzen Safety Scalpel #3L Handle
Published
2025-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDZHandle, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
48886354702636PackageGS110In Commercial Distribution
58886354702633PackageGS14In Commercial Distribution
38886354702639PrimaryGS10
18886354702635Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4888635470263648886354702636
5888635470263358886354702633
3888635470263938886354702639
1888635470263518886354702635

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(404) 855-3655sales@medipurpose.com

Regulatory Flags#

DUNS number
628380248
Device count
5
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
38886354703100SurgiLance Lite Safety LancetSLL25G2202025-05-20
48886354703107SurgiLance Lite Safety LancetSLL25G2202025-05-20
18886354702840SurgiLance Safety LancetSLN304W2025-02-12
28886354703059SurgiLance Safety LancetSLN2422025-02-12
28886354703097SurgiLance Safety LancetSLN2022025-02-12
38886354701861SurgiLance Safety LancetSLN3022025-02-12
38886354701892SurgiLance Safety LancetSLN3042025-02-12
38886354701908SurgiLance Safety LancetSLB2042025-02-12
38886354701915SurgiLance Safety LancetSLB2542025-02-12
58886354702640SurgiLance Safety LancetSLN30102025-02-12
58886354702855SurgiLance Safety LancetSLN10302025-02-12
58886354702848SurgiLance Safety LancetSLN304W2025-02-12
58886354703050SurgiLance Safety LancetSLN2422025-02-12
58886354703098SurgiLance Safety LancetSLN2022025-02-12
18886354701867SurgiLance Safety LancetSLN3022025-02-12
58886354701896SurgiLance Safety LancetSLN3042025-02-12
58886354701902SurgiLance Safety LancetSLB2042025-02-12
58886354701919SurgiLance Safety LancetSLB2542025-02-12
48886354702636Anzen Safety ScalpelAZH3L2025-02-12
18886354702642SurgiLance Safety LancetSLN30102025-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776396800MillenniumAvalign Technologies, Inc.GDZ2026-07-14
00850083275563Intrace USAPILOTIS TECH LLCGDZ2026-07-03
00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255726Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255788Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255801Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255825Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255863Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256105Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256112Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256129Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256136Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256150Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256174Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256181Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256198Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256204Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810189455139Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00190776421847MillenniumAvalign Technologies, Inc.GDZ2026-06-25
00810055257348Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257355Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257362Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257379Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257386Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257850Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00190776421533MillenniumAvalign Technologies, Inc.GDZ2026-05-05
00190776419769MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419776MillenniumAvalign Technologies, Inc.GDZ2026-04-15