FDA.reportPublic FDA data

SPECULUM

Primary DI
00888118116703
Brand
SPECULUM
Company
KLS-Martin L.P.
Model
32-160-02-01
Published
2018-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118116703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118116703008881181167038881181167030888118116703

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.

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

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Primary DI, Brand, Company table
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10649111069574Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
10649111069888Sklar InstrumentsSKLAR CORPORATIONHDF2025-03-18
G586OB631721NCDT0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
G586OB631723NCDT0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
G586OB633804NC0Novo SurgicalNOVO SURGICAL, INC.HDF2024-02-22
10653160294153CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-02
10653160294122CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
10653160294948CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
10653160306528CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHDF2022-01-01
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10381780500599Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHDF2018-09-18