FDA.reportPublic FDA data

Phantom Hindfoot TTC/TC Nail System

Primary DI
00889795130921
Brand
Phantom Hindfoot TTC/TC Nail System
Company
Paragon 28, Inc.
Model
P99-150-2008
Catalog number
P99-150-2008
Device description
Vice Grips
Published
2024-02-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795130921PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795130921008897951309218897951309210889795130921

GMDN Terms#

Term, Definition table
TermDefinition
Surgical vice gripA heavy-duty, hand-held, surgical instrument with specially designed sturdy handles and gripping jaws intended to be used to securely grip around or hold an object during a surgical intervention. It is made of high-grade stainless steel and is designed like an adjustable wrench and has handles that are self-locking when squeezed closed. The jaws are strong, typically having a concave grip with heavy serrations, and are pivoted with an adjustable ratio-lever exchange to achieve the optimum gripping aperture and gripping force. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
042961576
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795118011Monkey Rings™ External Fixation SystemP45-511-0001P45-511-00012026-05-06
00889795152114Monkey Rings™ External Fixation SystemP45-113-0120P45-113-01202026-05-06
00889795152121Monkey Rings™ External Fixation SystemP45-113-0140P45-113-01402026-05-06
00889795152138Monkey Rings™ External Fixation SystemP45-113-0160P45-113-01602026-05-06
00889795152145Monkey Rings™ External Fixation SystemP45-113-0180P45-113-01802026-05-06
00889795152152Monkey Rings™ External Fixation SystemP45-113-0200P45-113-02002026-05-06
00889795152169Monkey Rings™ External Fixation SystemP45-113-0220P45-113-02202026-05-06
00889795152176Monkey Rings™ External Fixation SystemP45-191-4650P45-191-46502026-05-06
00889795152183Monkey Rings™ External Fixation SystemP45-191-5055P45-191-50552026-05-06
00889795152190Monkey Rings™ External Fixation SystemP45-191-5070P45-191-50702026-05-06
00889795152206Monkey Rings™ External Fixation SystemP45-191-6055P45-191-60552026-05-06
00889795152213Monkey Rings™ External Fixation SystemP45-191-6070P45-191-60702026-05-06
00889795152244Monkey Rings™ External Fixation SystemP45-196-4650P45-196-46502026-05-06
00889795152251Monkey Rings™ External Fixation SystemP45-196-5055P45-196-50552026-05-06
00889795152268Monkey Rings™ External Fixation SystemP45-196-5070P45-196-50702026-05-06
00889795152275Monkey Rings™ External Fixation SystemP45-196-6055P45-196-60552026-05-06
00889795152282Monkey Rings™ External Fixation SystemP45-196-6070P45-196-60702026-05-06
00889795152299Monkey Rings™ External Fixation SystemP45-197-2333P45-197-23332026-05-06
00889795152367Monkey Rings™ External Fixation SystemP45-334-1000P45-334-10002026-05-06
00889795152374Monkey Rings™ External Fixation SystemP45-334-1001P45-334-10012026-05-06

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