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
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
00850083275808Intrace USAPILOTIS TECH LLCEPY2026-07-03
00850083275815Intrace USAPILOTIS TECH LLCEPY2026-07-03
00850083275877Intrace USAPILOTIS TECH LLCEPY2026-07-03
00810158216594PRINCETONPrinceton Medical Group, Inc.EPY2026-06-23
09348811148858INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148889INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148957INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-06-02
09348811148919INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
09348811148933INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-05-29
G043714000BEARBear-Ent, LLCEPY2026-05-07
G04371401G0GEIZBear-Ent, LLCEPY2026-05-07
G04371402G0GEIZBear-Ent, LLCEPY2026-05-07
G04371403G0GEIZBear-Ent, LLCEPY2026-05-07
09348811116673INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-04-24
09348811116925INKAThe Trustee for KAISER FAMILY TRUSTEPY2026-03-18
09348811116345INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116369INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116383INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116406INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811116413INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
09348811148995INKAThe Trustee for KAISER FAMILY TRUSTEPY2025-11-21
08906039319514OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319521OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319538OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
08906039319545OSSEOUS Ear SpeculaEON MEDITECH PRIVATE LIMITEDEPY2024-07-04
04250407704490FENTEXFENTEX medical GmbHEPY2022-12-07
04250407704766FENTEXFENTEX medical GmbHEPY2022-12-07
04250407704780FENTEXFENTEX medical GmbHEPY2022-12-07
G043608500BEARBear-Ent, LLCEPY2022-05-23
10381780403852Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONEPY2018-08-16