FDA.report

Baby Gorilla/Gorilla Plating System

Primary DI
00889795056412
Company
PARAGON 28, INC.
Model
P51-902-1002-T
Catalog number
P51-902-1002-T
Device description
Centering Drill Guide 3.5mm, TUFFNEK
Published
2019-10-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
042961576
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00889795056412PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00889795056412PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
FZXGuide, Surgical, Instrument1General, Plastic Surgery878.4800NEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

No records found.

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