FDA.reportPublic FDA data

Fast Fish®

Primary DI
00850013858033
Brand
Fast Fish®
Company
Stanley Medical Designs, Incorporated
Model
SP-WT-001
Catalog number
SP-WT-001
Device description
Fast Fish® Gauge
Published
2022-03-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZTCutter, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013858033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013858033008500138580338500138580330850013858033

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(305)-758-0211info@stanleymedicaldesigns.com

Regulatory Flags#

DUNS number
087844537
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013858118Flick-Catcher®SP-XSB-001SP-XSB-0012022-03-01
00850013858125Flick-Catcher®SP-XTB-001SP-XTB-0012022-03-01
00850013858040Flick-Catcher®SP-LSB-001SP-LSB-0012022-03-01
00850013858057Flick-Catcher®SP-RSB-001SP-RSB-0012022-03-01
00850013858064Flick-Catcher®SP-LTB-001SP-LTB-0012022-03-01
00850013858071Flick-Catcher®SP-RTB-001SP-RTB-0012022-03-01
00850013858088Moby®1510-01S1510-01S2022-03-01
00850013858095SoBe®1510-02S1510-02S2022-03-01
00850013858101SoBe®1510-03S1510-03S2022-03-01
10850013858115Flick-Catcher®SP-XSB-001SP-XSB-0012022-03-01
10850013858122Flick-Catcher®SP-XTB-001SP-XTB-0012022-03-01
00850013858002Moby® 1510-011510-012022-02-25
00850013858019SoBe® 1510-021510-022022-02-25
00850013858026SoBe® 1510-031510-032022-02-25

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00818069010997TecometTECOMET INC.FZT2023-08-10
05010058070837InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08
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