FDA.report

Ambler Surgical

Primary DI
00190660179205
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Hirschman rectal anoscope speculum
Catalog number
86-506
Device description
Hirschman rectal anoscope speculum, small, 2 1/4'' long x 9/16'' diameter
Published
2021-01-04
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
FXESPECULUM, NON-ILLUMINATED

Product Code Classifications

CodeDeviceSpecialtyClass
FXESpeculum, Non-IlluminatedGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660179205PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660179205001906601792051906601792050190660179205

GMDN Terms

TermDefinition
Proctoscope, reusableAn endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. Anatomical images are transmitted to the user by the device by direct or magnified viewing. This device is longer than an anoscope to provide a deeper view and it is typically equipped with illumination in the distal end. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags

DUNS number
015272206
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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