FDA.reportPublic FDA data

NA

Primary DI
03596010461087
Brand
NA
Company
Smith & Nephew, Inc.
Model
4550
Catalog number
4550
Device description
MTO CABLE HIGH ARC ABI
Published
2015-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOBNasopharyngoscope (Flexible Or Rigid)Ear, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010461087PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010461087035960104610873596010461087

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video imaging systemAn assembly of mains electricity (AC-powered) devices designed to obtain, transmit, and display video images during an endoscopic procedure. It typically consists of one or more video endoscopes, an endoscopic camera, camera control unit, light source with light cables, video recorder, imaging units with perhaps a colour compensation device, a distention unit, and a visual display unit (VDU), all of which is typically placed/mounted onto a trolley (cart) that can be moved to different examination/treatment rooms.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com

Regulatory Flags#

DUNS number
045483575
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03596010482280CLEAR-TRAC721012172101212015-10-22
03596010532619NA721071972107192015-08-30
03596010505132SCULPTOR721069772106972015-08-30
03596010505149SCULPTOR721069672106962015-08-30
03596010505170SCULPTOR721069572106952015-08-30
03596010505194SCULPTOR721070072107002015-08-30
00885554016703560P72202351722023512015-08-29
00885556919781Real IntelligenceROB30007ROB300072026-10-13
00885556924327Real IntelligenceROB30801ROB308012026-10-08
03596010445803NA720903072090302015-08-30
03596010470294SAPHYRE720968472096842015-08-30
03596010470331ABLATOR720965972096592015-08-30
03596010470348ABLATOR720965872096582015-08-30
03596010470416ABLATOR720965172096512015-08-30
03596010470577ABLATOR720965072096502015-08-30
03596010470614TAC-S720963272096322015-08-30
03596010448446TWINFIX720910972091092015-08-30
03596010470393ABLATOR720965372096532015-08-30
03596010470423ABLATOR720964972096492015-08-30
03596010510976NA721004072100402015-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826921001PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921056PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921063PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921070PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921117PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921148PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826921209PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922473PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826922497PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925719PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925726PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925948VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826925979PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926006VIVIDEOPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926174PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926181PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926310PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926327PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926358PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926433PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926440PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926457PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826926617PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826927034PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826927041PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04580826928710PENTAX MedicalPENTAX MEDICAL CORPORATIONEOB2026-08-25
04961333255528PENTAX MedicalHOYA CORPORATIONEOB2026-08-25
04961333256181PENTAXHOYA CORPORATIONEOB2026-08-25
07613327631395N/ASTRYKER CORPORATIONEOB2026-06-19
07613327631388N/ASTRYKER CORPORATIONEOB2026-06-16