FDA.report

Cusco Specula Insulated with Smoke Tube Large Extra Long

Primary DI
05060212057648
Brand
Cusco Specula Insulated with Smoke Tube Large Extra Long
Company
DTR MEDICAL LIMITED
Model
CSI100LE
Published
2024-10-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
HDFSpeculum, Vaginal, Metal

Product Code Classifications

CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05060212057648PackageGS110In Commercial Distribution
05060411982239PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05060212057648050602120576485060212057648
05060411982239050604119822395060411982239

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
424066509
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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05060212057563Sims Uterine SoundUSH20012024-10-14
05060212055460Aspiration Cannulae 70mm Angled, 1.4mm/17G74-1231A 2024-10-14
05060212055477Aspiration Cannulae 70mm Angled, 1.2mm/18G74-1232 2024-10-14
05060212055484Aspiration Cannulae 70mm Angled, 1.0mm/19G74-1232A 2024-10-14
05060212055576Aspiration Cannulae 70mm Angled, 0.9mm/20g74-1233 2024-10-14
05060212055583Aspiration Cannulae 70mm Angled, 0.7mm/22G74-1234 2024-10-14
05060212055590Aspiration Cannulae 70mm Angled, 0.55mm/24G74-1236 2024-10-14
05060212055606Aspiration Cannulae 80mm Angled, 2.0mm/14G74-1260 2024-10-14
05060212055613Aspiration Cannulae 80mm Angled, 1.0mm/19G74-1262A 2024-10-14
05060212055729Aspiration Cannulae 80mm Angled,1.4mm/17G74-1264 2024-10-14
05060212055736Aspiration Cannulae 70mm Angled, 1.6mm/16G74-12312024-10-14
05060212055743Aspiration Cannulae 80mm Angled, 1.7mm/15G74-12652024-10-14
05060212055750Aspiration Cannulae 80mm Angled, 2.5mm/13G74-1267 2024-10-14
05060212055767Aspiration Cannulae 80mm Angled, 3.0mm/11G74-12682024-10-14
05060212055873Aspiration Cannulae 100mm Angled, 3.0mm/11G74-1297 2024-10-14
05060212055910Brackmann type, 1.6mm x 115mm, 40 degree bend, suction control hole, open end74-2009 2024-10-14
05060212055927Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, without suction contro74-2011 2024-10-14
05060212056665Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012 2024-10-14
05060212057006Zoellner type, 2mm x 85mm, distal bend acute 30 degree angle, without suction co74-2012P 2024-10-14
05060212057013Zoellner type, 2mm x 85mm, 10 degree shallow distal bend, with suction control h74-2013 2024-10-14

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