FDA.reportPublic FDA data

EMPIRE SURGICAL INSTRUMENTS COMPANY

Primary DI
B92311138PP1
Brand
EMPIRE SURGICAL INSTRUMENTS COMPANY
Company
EMPIRE SURGICAL INSTRUMENTS COMPANY
Model
11-138-PP
Catalog number
11-138-PP
Device description
"IRIS SCISSORS 4.5"" STR PP"
Published
2022-09-01
Public version status
Update
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
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B92311138PP2PackageHIBCC1000In Commercial Distribution
B92311138PP1PrimaryHIBCC0
B92311138PP11Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, single-useA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+16466101307aizaz@finesurgical.com

Regulatory Flags#

DUNS number
645772133
Device count
50
DM exempt
true
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B923111500EMPIRE SURGICAL INSTRUMENTS COMPANY11-15911-1592023-10-27
B92311138PP2EMPIRE SURGICAL INSTRUMENTS COMPANY 11-138-PP11-138-PP2022-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898789390053KAYE FREEMAN FACE-LIFT SCISSORS CURVED 23CMTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDALRW2026-06-09
00810055251520Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810055251537Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450714Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450721Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450738Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450752Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189450998Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451018Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451032Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451056Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451070Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451513Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451568Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451728Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810189451735Surgical DesignSurgical Design, Inc.LRW2026-06-06
00810220800317Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800331Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800355Adler Instrument CompanyAdler, Inc.LRW2026-06-02
00810220800362Adler Instrument CompanyAdler, Inc.LRW2026-06-02
09348811115461INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-06-02
00810143908329SURGIPROSSurgipros, LLCLRW2026-06-01
00810212930688SURGIPROSSurgipros, LLCLRW2026-06-01
B356BK211110American MedicalsAmerican MedicalsLRW2026-05-29
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00846159039740SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27
00846159039757SCANLAN® ScissorsSCANLAN INTERNATIONAL INCLRW2026-05-27