FDA.reportPublic FDA data

Surgical Design

Primary DI
00810189451704
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
DS-15
Device description
Orbital Dissection Barraquer Eye Speculum
Published
2026-06-10
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810189451704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810189451704008101894517048101894517040810189451704

GMDN Terms#

Term, Definition table
TermDefinition
Eyelid speculum, single-useA self-retaining ophthalmic surgical instrument intended to be used to retract the eyelids during an ophthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours. This is a single-use device.

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
D955SPCM1Paul BandittTerlain Enterprises, Inc.EPY2026-09-25
00190776432256MillenniumAvalign Technologies, Inc.EPY2026-09-24
00810238290094PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290100PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290117PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
00810238290124PRINCETONPrinceton Medical Group, Inc.EPY2026-09-22
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