FDA.reportPublic FDA data

EMPIRE SURGICAL INSTRUMENTS COMPANY

Primary DI
B92311138PP2
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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 non-dedicated hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with finger and thumb ring-handles whereby the shearing action is directly adjacent to the handles (i.e., not alligator or endoscopic design). It is made of metal and available in a variety of blade designs; the blades may 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
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
B923111500EMPIRE SURGICAL INSTRUMENTS COMPANY11-15911-1592023-10-27
B92311138PP1EMPIRE SURGICAL INSTRUMENTS COMPANY 11-138-PP11-138-PP2022-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776407568MillenniumAvalign Technologies, Inc.LRW2026-08-03
00190776422783MillenniumAvalign Technologies, Inc.LRW2026-08-03
00190776422868MillenniumAvalign Technologies, Inc.LRW2026-08-03
00190776407476MillenniumAvalign Technologies, Inc.LRW2026-07-31
00190776422493MillenniumAvalign Technologies, Inc.LRW2026-07-31
00190776422608MillenniumAvalign Technologies, Inc.LRW2026-07-31
00190776422202MillenniumAvalign Technologies, Inc.LRW2026-07-28
00198506092800ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093036ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093326ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093401ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
B382SD9037871020Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871030Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871090Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741050Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741100Surgical DirectSurgical Direct, Inc.LRW2026-07-28
00190776405915MillenniumAvalign Technologies, Inc.LRW2026-07-26
00190776422028MillenniumAvalign Technologies, Inc.LRW2026-07-24
00190776421908MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776421922MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776403256MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403300MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403669MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776400392MillenniumAvalign Technologies, Inc.LRW2026-07-17
00840183531546BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531553BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531577BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531614BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531645BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531706BR Surgical, LLCBR Surgical, LLCLRW2026-07-17