FDA.report

PILLING

Primary DI
04026704513864
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN004306
Catalog number
202097
Device description
HIRSCHMANN ANOSCOPE LARGE
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FERAnoscope and accessories
FFQSPECULUM, RECTAL

Product Code Classifications

CodeDeviceSpecialtyClass
FERAnoscope And AccessoriesGastroenterology, Urology2
FFQSpeculum, RectalGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704513864Direct MarkingGS10
24026704513868PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704513864040267045138644026704513864
2402670451386824026704513868

GMDN Terms

TermDefinition
Anoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a light source and can be viewed by the user through relayed lens optics or direct vision. This device is commonly used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a reusable device.

Device Sizes

TypeValueUnit
Length2.75Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
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

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