FDA.reportPublic FDA data

SPECULUM

Primary DI
00888118055187
Brand
SPECULUM
Company
KLS-Martin L.P.
Model
30-615-15-01
Device description
RECTAL, SIMS, FENESTRATED, 70 X 15 MM BLADE
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
FFQSPECULUM, RECTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118055187PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118055187008881180551878881180551870888118055187

GMDN Terms#

Term, Definition table
TermDefinition
Rectal speculumA hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. 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
00888118108357DISTRACTION, INTERNAL, STERILE51-556-20-812018-09-26
00888118108364DISTRACTION, INTERNAL, STERILE51-557-20-812018-09-26
00888118147226LEVEL ONE EXTREMITY26-950-64-042026-07-21
00888118147233LEVEL ONE EXTREMITY26-950-65-042026-07-21
00888118147240LEVEL ONE EXTREMITY26-950-66-042026-07-21
00888118147257LEVEL ONE EXTREMITY26-950-67-042026-07-21
00888118147264LEVEL ONE EXTREMITY26-950-68-042026-07-21
00888118147271LEVEL ONE EXTREMITY26-950-69-042026-07-21
00888118147714LEVEL ONE EXTREMITY26-950-58-042026-07-21
00888118147721LEVEL ONE EXTREMITY26-950-59-042026-07-21
00888118147738LEVEL ONE EXTREMITY26-950-62-042026-07-21
00888118147745LEVEL ONE EXTREMITY26-950-63-042026-07-21
00888118154620LEVEL ONE CMF25-315-92-912026-07-21
00888118154637LEVEL ONE CMF50-743-06-092026-07-21
00888118154644LEVEL ONE, STERILE25-433-97-712026-07-21
00888118154651LEVEL ONE, STERILE25-438-97-712026-07-21
00888118154668LEVEL ONE, STERILE25-439-91-712026-07-21
00888118154675LEVEL ONE, STERILE25-486-97-712026-07-21
00888118154682LEVEL ONE, STERILE25-487-97-712026-07-21
00888118154699LEVEL ONE, STERILE50-817-15-712026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432362MillenniumAvalign Technologies, Inc.FFQ2026-09-24
00860015748508Thermora AnoscopeOMEC Medical (NV) Inc.FFQ2026-07-31
00190776422189MillenniumAvalign Technologies, Inc.FFQ2026-07-28
00850048720619Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720626Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720633Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720640Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720732Speculum KitsSpecialty Health Products, LLCFFQ2026-07-23
00850048720541Speculum KitsSpecialty Health Products, LLCFFQ2026-07-22
05055445961107SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961114SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961121SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961138SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961145SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961152SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961169SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961176SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961183SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961190SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961206SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961213SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961220SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961237SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961244SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961251SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961282SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961299SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961305SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961312SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12
05055445961329SurtexSURTEX INSTRUMENTS LTD.FFQ2026-05-12