FDA.reportPublic FDA data

Cottle Nasal Speculum 35mm/15cm

Primary DI
G25010035010
Brand
Cottle Nasal Speculum 35mm/15cm
Company
N S SURGICAL COMPANY
Model
10-035-01
Catalog number
10-035-01
Device description
A hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.
Published
2023-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EPYSpeculum, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G25010035010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, reusableA hand-held surgical instrument inserted into a nostril and manually expanded to maximally open the nostril by stretching the tissue around the nasal orifice, allowing access for examination or ear/nose/throat (ENT) surgical intervention. The device is made of high-grade stainless steel and has two blunt, contoured blades that are expanded by applying pressure to the pivoted handles. The handles are typically attached to springs so that they close upon release of the pressure applied to them. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length15Centimeter

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ultraviolet Light"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;Ultraviolet Light;Ethylene Oxide

Regulatory Flags#

DUNS number
645681649
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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G25009069160Inge Spreader (Child) 16cm09-069-1609-069-162023-09-02
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G25012102180Volkmann Curette 5.2mm/17cm Straight12-102-1712-102-172023-09-02
G25012191240Lambotte Osteotomes Straight 38mm12-191-2412-191-242023-09-02
G25012195240Lambotte Osteotomes Curved 13mm12-195-2412-195-242023-09-02
G25010005140Laborde Dilator Forcep10-005-1410-005-142023-04-29
G25003140150Debakey Forceps 1.5mm/15cm03-140-1503-140-152023-04-28
G25003168240Debakey Satinsky Forceps 24cm03-168-2403-168-242023-04-28
G25003178000Vasectomy Set of 203-178-0003-178-002023-04-29
G25008036030Penfield Elevator08-036-0308-036-032023-04-28
G25009006010Volkmann Retractor 1 Prong Sharp09-006-0109-006-012023-04-29
G25009047020Weitlaner Retractor 20cm Blunt 3x409-047-0209-047-022023-04-28
G25009047190Anderson Retractor 19cm Blunt 4x409-047-1909-047-192023-04-28
G25009050130Weitlaner Retractor 14cm Blunt09-050-1309-050-132023-04-28
G25010034030Killian Nasal Speculum 75mm/13cm10-034-0310-034-032023-04-29
G25010035020Cottle Nasal Speculum 50mm/15cm10-035-0210-035-022023-04-29

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