FDA.reportPublic FDA data

Anzen Safety Scalpel

Primary DI
48886354702636
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
Rx
false
OTC
false
Sterile
false
Single use
false

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
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
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
38886354702639Anzen Safety ScalpelAZH3L2025-02-12
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
18886354702642SurgiLance Safety LancetSLN30102025-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327651188VersiQuadSTRYKER CORPORATIONGDZ2026-07-22
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