FDA.reportPublic FDA data

Cusco Specula Insulated with Smoke Tube Large Long

Primary DI
05060411982222
Brand
Cusco Specula Insulated with Smoke Tube Large Long
Company
DTR MEDICAL LIMITED
Model
CSI100LL
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
05060212057631PackageGS110In Commercial Distribution
05060411982222PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060212057631050602120576315060212057631
05060411982222050604119822225060411982222

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, single-useA 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 typically 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 to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.

Regulatory Flags#

DUNS number
424066509
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060411985339Cervical Biopsy Punch1CBR10412021-11-09
05060212052162Sims Uterine SoundUSH20012024-10-14
05060411980471Aspiration Cannulae 70mm Angled, 1.4mm/17G74-1231A 2024-10-14
05060411980662Aspiration Cannulae 70mm Angled, 1.2mm/18G74-1232 2024-10-14
05060411980730Aspiration Cannulae 70mm Angled, 1.0mm/19G74-1232A 2024-10-14
05060411980747Aspiration Cannulae 70mm Angled, 0.9mm/20g74-1233 2024-10-14
05060411980792Aspiration Cannulae 70mm Angled, 0.7mm/22G74-1234 2024-10-14
05060411980853Aspiration Cannulae 70mm Angled, 0.55mm/24G74-1236 2024-10-14
05060411980860Aspiration Cannulae 80mm Angled, 2.0mm/14G74-1260 2024-10-14
05060411981218Aspiration Cannulae 80mm Angled, 1.0mm/19G74-1262A 2024-10-14
05060411981225Aspiration Cannulae 80mm Angled,1.4mm/17G74-1264 2024-10-14
05060411981232Aspiration Cannulae 70mm Angled, 1.6mm/16G74-12312024-10-14
05060411981249Aspiration Cannulae 80mm Angled, 1.7mm/15G74-12652024-10-14
05060411981256Aspiration Cannulae 80mm Angled, 2.5mm/13G74-1267 2024-10-14
05060411981263Aspiration Cannulae 80mm Angled, 3.0mm/11G74-12682024-10-14
05060411981270Aspiration Cannulae 100mm Angled, 3.0mm/11G74-1297 2024-10-14
05060411981386Brackmann type, 1.6mm x 115mm, 40 degree bend, suction control hole, open end74-2009 2024-10-14
05060411981560Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, without suction contro74-2011 2024-10-14
05060411981577Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012 2024-10-14
05060411981799Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012P 2024-10-14

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