FDA.reportPublic FDA data

NA

Primary DI
07613327059472
Brand
NA
Company
STRYKER CORPORATION
Model
0502555400
Catalog number
0502555400
Device description
Biopsy Cup, Semi-flexible, 5 Fr.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAJCystoscope and accessories, flexible/rigid
FASELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
HIHHYSTEROSCOPE (AND ACCESSORIES)
KQTEVACUATOR, GASTRO-UROLOGY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAJCystoscope And Accessories, Flexible/RigidGastroenterology, Urology2
FASElectrode, Electrosurgical, Active, UrologicalGastroenterology, Urology2
HIHHysteroscope (And Accessories)Obstetrics/Gynecology2
KQTEvacuator, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327059472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327059472076133270594727613327059472

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy forceps, reusableA flexible, manual, non-electrosurgical instrument intended to obtain tissue specimens during endoscopic procedures (e.g., gastro-urological endoscopy, laparoscopy, bronchoscopy, laryngoscopy) for histopathological examination. It is typically a flexible metal coil with a pair of scissors-like cups with cutting edge rims, which are operated by a control handle at the proximal end of the instrument. It is introduced into the body through an artificial orifice of the body or the working channel of the endoscope. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length41Centimeter

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327625172Steri-Shield04248010000424-801-0002025-02-21
07613327625257Steri-Shield04247212000424-721-2002025-02-21
07613327625288Steri-Shield04247412000424-741-2002025-02-21
07613327625295Steri-Shield04248211000424-821-1002025-02-21
07613327625332Steri-Shield04248212000424-821-2002025-02-21
07613327625349Steri-Shield04248312000424-831-2002025-02-21
07613327625363Steri-Shield04248512000424-851-2002025-02-21
07613327625370Steri-Shield04249210000424-921-0002025-02-21
07613327625387Steri-Shield04249410000424-941-0002025-02-21
07613327625394Steri-Shield04249510000424-951-0002025-02-21
07613327625400Steri-Shield04249310000424-931-0002025-02-21
07613327625417Steri-Shield04249412000424-941-2002025-02-21
07613327625424Steri-Shield04249311000424-931-1002025-02-21
07613327625431Steri-Shield04249211000424-921-1002025-02-21
07613327625448Steri-Shield04249312000424-931-2002025-02-21
07613327625455Steri-Shield04249512000424-951-2002025-02-21
07613327625462Steri-Shield04249212000424-921-2002025-02-21
07613327625479Steri-Shield04249511000424-951-1002025-02-21
07613327625486Steri-Shield04249411000424-941-1002025-02-21
07613327465655Neptune0703-046-0060703-046-0062019-10-16

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Primary DI, Brand, Company table
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00850023925954WiScope®Otu Medical Inc.FAJ2026-07-28
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00850023925992WiScope®Otu Medical Inc.FAJ2026-07-28
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06972084140627AptraNingbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140665WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140672WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140689WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
06972084140696WiScope®Ningbo Wise Optomech Technology CorporationFAJ2026-07-28
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