FDA.reportPublic FDA data

Baby Gorilla®/Gorilla® Plating System

Primary DI
00889795112545
Brand
Baby Gorilla®/Gorilla® Plating System
Company
Paragon 28, Inc.
Model
P50-900-GLID
Catalog number
P50-900-GLID
Device description
Gorilla, Caddy, General Lid
Published
2022-09-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795112545PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795112545008897951125458897951125450889795112545

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042961576
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
Sterilization required before use
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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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327631876RPSSTRYKER CORPORATIONFSM2025-10-01
07613327681741N/ASTRYKER CORPORATIONFSM2025-09-03
ESAM23080001STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080161STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6550401STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
07630894802683APTUSMedartis AGFSM2023-02-24
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07630894803314APTUSMedartis AGFSM2023-02-24
07630894803321APTUSMedartis AGFSM2023-02-24
07630894803338APTUSMedartis AGFSM2023-02-24
07630894803345APTUSMedartis AGFSM2023-02-24
07630894803369APTUSMedartis AGFSM2023-02-24
07630894803383APTUSMedartis AGFSM2023-02-24
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07630894803413APTUSMedartis AGFSM2023-02-24