FDA.reportPublic FDA data

Snowden-Pencer

Primary DI
10885403151910
Brand
Snowden-Pencer
Company
STERIS CORPORATION
Model
88-1435
Catalog number
881435
Device description
Snowden-Pencer SPECULUM COTTLE 14CM 5-1/2 inches, 50MM 2 inches
Published
2018-07-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
10885403151910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540315191010885403151910

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995248444Snowden-Pencer886118V886118V2026-10-27
00724995248451Snowden-Pencer886122V886122V2026-10-27
00724995248468Snowden-Pencer886127V886127V2026-10-27
10885403035562V. MuellerCH8680CH86802020-04-15
10885403035579V. MuellerCH8680-001CH86800012020-04-15
10885403035586V. MuellerCH8681CH86812020-04-15
10885403022470V. MuellerRH600RH6002018-09-14
10885403092084V. MuellerOP0907-601OP09076012018-09-05
10885403092091V. MuellerOP0907-602OP09076022018-09-05
10885403099120V. MuellerOP5000OP50002018-09-07
10885403099137V. MuellerOP5005OP50052018-09-07
10885403099144V. MuellerOP5500OP55002018-09-07
10885403099182V. MuellerOP5505OP55052018-09-07
10885403099199V. MuellerOP5510OP55102018-09-07
10885403099205V. MuellerOP5520OP55202018-09-07
10885403099625V. MuellerOP5666OP56662019-01-02
10885403099717V. MuellerOP5700OP57002019-01-02
10885403099779V. MuellerOP5760OP57602019-01-02
10885403099786V. MuellerOP5761OP57612019-01-02
10885403104909V. MuellerOS4610OS46102018-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04250676750662Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750679Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750686Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750693Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750709Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750716Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750723Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750730Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750761Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750778Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750785Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750792Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750808Hartmann ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750945Tieck-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750952Tieck-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750969Vienna model nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750976Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750983Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676750990Hartmann-Halle nasal speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751003Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751010Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751027Killian septum speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751041Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751058Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751065Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751072Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751089Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751096Le Mee ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751102Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28
04250676751119Farrior ear speculumSpiggle & Theis Medizintechnik GmbHEPY2026-10-28