FDA.reportPublic FDA data

SPECULUM

Primary DI
00888118055415
Brand
SPECULUM
Company
KLS-Martin L.P.
Model
34-110-03-01
Device description
PEDIATRIC, EYE, WIRE, BARRAQUER, COLIBRI
Published
2018-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNCSpecula, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNCSpecula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118055415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118055415008881180554158881180554150888118055415

GMDN Terms#

Term, Definition table
TermDefinition
Periocular/lacrimal retractor, hand-held, reusableA hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810189451681Surgical DesignSurgical Design, Inc.HNC2026-05-23
00810189451698Surgical 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