FDA.report

Ambler Surgical

Primary DI
00190660210458
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Graves view-more vaginal speculum
Catalog number
86-368
Device description
Graves view-more vaginal speculum, medium, 4'' long x 1 1/4'' wide blades
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
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications

CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190660210458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660210458001906602104581906602104580190660210458

GMDN Terms

TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. 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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