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
00810055255689Surgical Design271-RD2026-06-26
00810055255696Surgical Design271-PR2026-06-26
00810055255702Surgical Design271-PK2026-06-26
00810055255726Surgical Design271-BL2026-06-26
00810055255788Surgical Design270-PK2026-06-26
00810055255801Surgical Design270-OR2026-06-26
00810055255825Surgical Design270-GR2026-06-26
00810055255863Surgical Design270-BL2026-06-26
00810055256105Surgical Design278PL-RD2026-06-26
00810055256112Surgical Design278PL-GR2026-06-26
00810055256129Surgical Design278PL-BL2026-06-26
00810055256136Surgical Design271PL-RD2026-06-26
00810055256150Surgical Design271PL-BL2026-06-26
00810055256174Surgical Design270PL-RD2026-06-26
00810055256181Surgical Design270PL-GR2026-06-26
00810055256198Surgical Design270PL-BL2026-06-26
00810055256204Surgical Design270PL-BK2026-06-26
00810189455139Surgical Design271-08P2026-06-26
00810055259342Surgical DesignMSS-475-STR2026-06-25
00810055259359Surgical DesignMSS-475-CVD2026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405823MillenniumAvalign Technologies, Inc.GEN2026-07-26
00190776405915MillenniumAvalign Technologies, Inc.LRW2026-07-26
00190776422028MillenniumAvalign Technologies, Inc.LRW2026-07-24
00190776422127MillenniumAvalign Technologies, Inc.GEN2026-07-24
00190776421908MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776421922MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776421946MillenniumAvalign Technologies, Inc.GEN2026-07-23
B382SD905701100Surgical DirectSurgical Direct, Inc.FHQ2026-07-23
00190776403881MillenniumAvalign Technologies, Inc.GEN2026-07-22
00190776403980MillenniumAvalign Technologies, Inc.GEN2026-07-22
00198506092138ELMED INCORPORATEDELMED INCORPORATEDGEN2026-07-22
00840183531980BR Surgical, LLCBR Surgical, LLCFHQ2026-07-22
00840183532093BR Surgical, LLCBR Surgical, LLCGEN2026-07-22
00190776400514MillenniumAvalign Technologies, Inc.GEN2026-07-21
00190776403256MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403300MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403355MillenniumAvalign Technologies, Inc.GEN2026-07-21
00190776403379MillenniumAvalign Technologies, Inc.GEN2026-07-21
00190776403669MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403751MillenniumAvalign Technologies, Inc.FHQ2026-07-21
00840183531720BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532475BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183532499BR Surgical, LLCBR Surgical, LLCFHQ2026-07-21
00840183531423BR Surgical, LLCBR Surgical, LLCGEN2026-07-20
00840183532321BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00840183533076BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00190776402112MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776402136MillenniumAvalign Technologies, Inc.GEN2026-07-19
00190776400255MillenniumAvalign Technologies, Inc.GEN2026-07-17
00190776400392MillenniumAvalign Technologies, Inc.LRW2026-07-17