FDA.report

Welch Allyn, Inc.

Primary DI
00732094239331
Brand
Welch Allyn, Inc.
Company
WELCH ALLYN, INC.
Model
901117
Catalog number
328044-505
Device description
Obturator Assembly, for Model 33020 Fiber Optic/Stricture, Speculum
Published
2023-04-25
Public version status
New
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

Product Code Classifications

CodeDeviceSpecialtyClass
FERAnoscope And AccessoriesGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00732094239331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00732094239331007320942393317320942393310732094239331

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM

Regulatory Flags

DUNS number
198227881
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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08033638801192AdaptorSAPI MED SPAFER2023-08-02
08033638800447Self-light anoscopesSAPI MED SPAFER2023-07-27
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