FDA.reportPublic FDA data

Surgical Design

Primary DI
00810055258567
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
LAC-SET5
Device description
Laceration Kit - Set of 5
Published
2026-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHQHolder, Needle, Gastroenterologic
GENForceps, General & Plastic Surgery
HRQHemostat
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1
HRQHemostatGeneral, Plastic Surgery1
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810055258567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810055258567008100552585678100552585670810055258567

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Ethylene Oxide
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
7035410196info@surgical-design.com

Regulatory Flags#

DUNS number
112617522
Device count
1
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810055255184Surgical DesignSD-DS-SS-10-BX2026-09-26
00810055255191Surgical DesignSD-DS-SS-11-BX2026-09-26
00810055255207Surgical DesignSD-DS-SS-12-BX2026-09-26
00810055255214Surgical DesignSD-DS-SS-12B-BX2026-09-26
00810055255238Surgical DesignSD-DS-SS-15-BX2026-09-26
00810055255245Surgical DesignSD-DS-SS-21-BX2026-09-26
00810055255252Surgical DesignSD-DS-SS-22-BX2026-09-26
00810055255269Surgical DesignSD-DS-SS-23-BX2026-09-26
00810055255276Surgical DesignSD-DS-SS-24-BX2026-09-26
00810055255283Surgical DesignSD-DS-SS-20-BX2026-09-26
00810055255290Surgical DesignSD-SB-CS-10-BX2026-09-26
00810055255313Surgical DesignSD-SB-CS-11-BX2026-09-26
00810055255320Surgical DesignSD-SB-CS-12-BX2026-09-26
00810055255337Surgical DesignSD-SB-CS-12B-BX2026-09-26
00810055255368Surgical DesignSD-SB-CS-15-BX2026-09-26
00810055255382Surgical DesignSD-SB-CS-15C-BX2026-09-26
00810055255429Surgical DesignSD-SB-CS-20-BX2026-09-26
00810055255436Surgical DesignSD-SB-CS-21-BX2026-09-26
00810055255443Surgical DesignSD-SB-CS-22-BX2026-09-26
00810055255450Surgical DesignSD-SB-CS-23-BX2026-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435479MillenniumAvalign Technologies, Inc.LRW2026-10-20
00190776436629MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776436728MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776439712MilleniumAvalign Technologies, Inc.LRW2026-10-20
04046826023379MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHRQ2026-10-20
B356111PL87514ST0steriSTATAmerican MedicalsLRW2026-10-20
00190776435325MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435332MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435400MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435448MillenniumAvalign Technologies, Inc.GEN2026-10-19
00190776435189MillenniumAvalign Technologies, Inc.LRW2026-10-16
00840329838669N/ABLACK & BLACK SURGICAL, INC.GEN2026-10-15
00190776434892MillenniumAvalign Technologies, Inc.FHQ2026-10-14
00190776434915MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435011MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435035MillenniumAvalign Technologies, Inc.GEN2026-10-14
00190776435042MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435059MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435066MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435073MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776434816MillenniumAvalign Technologies, Inc.GEN2026-10-13
B382SD9055891010Surgical DirectSurgical Direct, Inc.FHQ2026-10-13
00190776434649MillenniumAvalign Technologies, Inc.LRW2026-10-12
00190776434779MillenniumAvalign Technologies, Inc.GEN2026-10-12
00190776434793MillenniumAvalign Technologies, Inc.LRW2026-10-12
04058749012842NAFehling Instruments GmbH & Co. KGGEN2026-10-12
00190776434175MillenniumAvalign Technologies, Inc.GEN2026-10-09
00198506095801ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095818ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09
00198506095825ELMED INCORPORATEDELMED INCORPORATEDGEN2026-10-09