FDA.reportPublic FDA data

STINGRAY SURGICAL PRODUCTS

Primary DI
B112G920050
Brand
STINGRAY SURGICAL PRODUCTS
Company
STINGRAY SURGICAL PRODUCTS L.L.C.
Model
G92-005
Catalog number
G92-005
Device description
"Graves Speculum Insulated Large, 4.5"" (11.4cm) x 1.5"" (3.8cm), Evacuation Tube, Stainless Steel"
Published
2021-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HDFSpeculum, Vaginal, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B112G920050PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(561)210-7582udi@stingraysurgical.com

Regulatory Flags#

DUNS number
024328124
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B112G920260STINGRAY SURGICAL PRODUCTSG92-026G92-0262021-05-20
B112G921310STINGRAY SURGICAL PRODUCTSG92-131G92-1312021-05-19
B112G921320STINGRAY SURGICAL PRODUCTSG92-132G92-1322021-05-19
B112S03240FGU45Z0STINGRAY SURGICAL PRODUCTSS03-240FGU45Z2023-11-07
B112S03240FGZ0STINGRAY SURGICAL PRODUCTSS03-240FGZ2023-11-07
B112S031390NS0STINGRAY SURGICAL PRODUCTSS031-390NSS031-390NS2021-05-25
B112G030080STINGRAY SURGICAL PRODUCTSG03-008G03-0082021-05-20
B112G030100STINGRAY SURGICAL PRODUCTSG03-010G03-0102021-05-20
B112G030120STINGRAY SURGICAL PRODUCTSG03-012G03-0122021-05-20
B112G030140STINGRAY SURGICAL PRODUCTSG03-014G03-0142021-05-20
B112G030160STINGRAY SURGICAL PRODUCTSG03-016G03-0162021-05-20
B112G030180STINGRAY SURGICAL PRODUCTSG03-018G03-0182021-05-20
B112G031060STINGRAY SURGICAL PRODUCTSG03-106G03-1062021-05-20
B112G031080STINGRAY SURGICAL PRODUCTSG03-108G03-1082021-05-20
B112G031100STINGRAY SURGICAL PRODUCTSG03-110G03-1102021-05-20
B112G031120STINGRAY SURGICAL PRODUCTSG03-112G03-1122021-05-20
B112G031140STINGRAY SURGICAL PRODUCTSG03-114G03-1142021-05-20
B112G031160STINGRAY SURGICAL PRODUCTSG03-116G03-1162021-05-20
B112G031180STINGRAY SURGICAL PRODUCTSG03-118G03-1182021-05-20
B112G032060STINGRAY SURGICAL PRODUCTSG03-206G03-2062021-05-20

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