FDA.report

Surgical Design

Primary DI
00810189451698
Brand
Surgical Design
Company
Surgical Design, Inc.
Model
08-921-01
Device description
Orbital Dissection Clark Eye Speculum
Published
2026-05-23
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

Related Records

Contact Domains

Product Codes

CodeName
HNCSpecula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810189451698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810189451698008101894516988101894516980810189451698

GMDN Terms

TermDefinition
Eyelid speculum, reusableA self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic 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 and is usually made of stainless steel. This is a reusable device.

Sterilization Methods

Method
Ethylene Oxide
Moist Heat or Steam Sterilization

Contacts

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 DIBrandModelCatalogPublished
00810055250547Surgical Design141-07R-BL2026-05-26
00810055256211Surgical Design141-07-O2026-05-26
00810055256235Surgical Design141-07-PK2026-05-26
00810055256242Surgical Design141-07-RD2026-05-26
00810055256259Surgical Design141-07-YW2026-05-26
00810055258604Surgical Design141-07R2026-05-26
00810055258611Surgical Design141-07R-RD2026-05-26
00810055258628Surgical Design141-07R-GR2026-05-26
00810055258635Surgical Design141-07R-PK2026-05-26
00810055258642Surgical Design141-07R-PR2026-05-26
00810055258659Surgical Design141-07R-WH2026-05-26
00810055258666Surgical Design141-07R-TL2026-05-26
00810055258673Surgical Design141-07R-WY2026-05-26
00810055258680Surgical Design141-07F2026-05-26
00810055258697Surgical Design141-07-BL2026-05-26
00810055258703Surgical Design141-07-GR2026-05-26
00810055258710Surgical Design141-07-PR2026-05-26
00810055258727Surgical Design141-07-WH2026-05-26
00810055259663Surgical Design159R2026-05-26
00810055259670Surgical Design160R2026-05-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810189451681Surgical DesignSurgical Design, Inc.HNC2026-05-23
00810189451711Surgical DesignSurgical Design, Inc.HNC2026-05-23
00757770683741Bausch + LombBausch & Lomb IncorporatedHNC2026-02-04
05056785302988Kratz Plastic Mechanical SpeculumBLINK MEDICAL LIMITEDHNC2026-02-04
05056785303008Plastic Solid Bladed Mechanical SpeculumBLINK MEDICAL LIMITEDHNC2026-02-04
00840319758533Hayden MedicalHayden Medical, Inc.HNC2025-12-31
00840319758380Hayden MedicalHayden Medical, Inc.HNC2025-12-24
00852194002113HAI SpeculaHightech American Industrial Labs IncHNC2025-12-16
00757770652013Bausch + LombBausch & Lomb IncorporatedHNC2025-11-14
05060480409538Speculum LeibingerBLINK MEDICAL LIMITEDHNC2025-09-18
00190776410742MillenniumAvalign Technologies, Inc.HNC2025-09-12
00190776409456MillenniumAvalign Technologies, Inc.HNC2025-09-02
00190776408411MillenniumAvalign Technologies, Inc.HNC2025-08-08
00757770461974Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770481828Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770502462Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770503292Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00757770636891Bausch + LombBausch & Lomb IncorporatedHNC2025-08-05
00194613009984MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010058MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010140MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010164MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010171MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010188MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010317MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010331MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010386MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010423MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010447MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01
00194613010485MSI Precision Specialty InstrumentsMed Saver, Inc.HNC2025-08-01