FDA.report

Wingman

Primary DI
37613327061285
Brand
Wingman
Company
STRYKER CORPORATION
Model
0240240003
Catalog number
0240-240-003
Device description
Tube Set/Activation Button for Scope Holder, Do not use if package is damaged
Published
2016-09-23
Public version status
Update
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

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
37613327061285PackageGS112In Commercial Distribution
07613327061284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3761332706128537613327061285
07613327061284076133270612847613327061284

GMDN Terms

TermDefinition
Neurological endoscope holderA device intended to be used to hold and fix in position a rigid or flexible endoscope during a diagnostic or therapeutic neurological procedure. It is typically made of high-grade stainless steel and anodized aluminium and will usually be affixed to the operating/examination table enabling the surgeon to freely use both hands. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags

DUNS number
187502109
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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