FDA.report

Baby Gorilla/Gorilla Plating System

Primary DI
00889795039859
Brand
Baby Gorilla/Gorilla Plating System
Company
PARAGON 28, INC.
Model
P51-921-0001
Catalog number
P51-921-0001
Device description
5th Met Hook Plate Tamp, Single
Published
2019-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HXGTAMP

Product Code Classifications

CodeDeviceSpecialtyClass
HXGTampOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889795039859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795039859008897950398598897950398590889795039859

GMDN Terms

TermDefinition
Surgical tamp, reusableA hand-held, surgical instrument designed to be used to manually pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of metal, however some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure to the device or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
042961576
Device count
1
DM exempt
false
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

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00889795153852Baby Gorilla/Gorilla Plating SystemP50-900-BGSL-2P50-900-BGSL-22026-02-19
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00889795153944Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-3P50-900-SBSL-32026-02-19
00889795153951Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-4P50-900-SBSL-42026-02-19
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00889795153982Baby Gorilla/Gorilla Plating SystemP50-900-SBSL-7P50-900-SBSL-72026-02-19
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00889795118400APEX 3D Total Ankle Replacement SystemP99-152-P104-SP99-152-P104-S2026-01-28
00889795118417APEX 3D Total Ankle Replacement SystemP99-152-P105-SP99-152-P105-S2026-01-28

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