FDA.reportPublic FDA data

Moby®

Primary DI
00850013858002
Brand
Moby®
Company
Stanley Medical Designs, Incorporated
Model
1510-01
Catalog number
1510-01
Device description
Green Moby® Jointed Cutter Assembly
Published
2022-02-25
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
00850013858002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013858002008500138580028500138580020850013858002

GMDN Terms#

Term, Definition table
TermDefinition
Wire cutterA heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device.

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
Serial number
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
00850013858033Fast Fish®SP-WT-001SP-WT-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
00850013858019SoBe® 1510-021510-022022-02-25
00850013858026SoBe® 1510-031510-032022-02-25

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Primary DI, Brand, Company table
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10649111078910Sklar InstrumentsSKLAR CORPORATIONFZT2025-01-21
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00850037506262MACI Arthroscopic InstrumentsVERICEL CORPORATIONFZT2024-09-18
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00714646000781SutureOutBionix, LLCFZT2024-04-23
00714646001184SutureOutBionix, LLCFZT2024-04-23
10197106247327CARDINAL HEALTHCardinal Health 200, LLCFZT2023-09-14
00818069010997TecometTECOMET INC.FZT2023-08-10
05010058070837InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08
05010058070950InstrapacROBINSON HEALTHCARE LIMITEDFZT2023-08-08