FDA.report

Baby Gorilla/Gorilla Plating System

Primary DI
00889795040787
Brand
Baby Gorilla/Gorilla Plating System
Company
PARAGON 28, INC.
Model
P99-150-0011
Catalog number
P99-150-0011
Device description
Caspar Type Compression/Distraction Device
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
HWNINSTRUMENT, COMPRESSION

Product Code Classifications

CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889795040787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795040787008897950407878897950407870889795040787

GMDN Terms

TermDefinition
Osteotomy compression/distraction instrumentA non-sterile manual surgical instrument intended to be used for compression and distraction of an osteotomy. It is comprised of two arms that attach to pins/screws/nails inserted into both sides of the cut bone, and includes a mechanism (e.g., screw) used to close and open the arms of the device enabling compression and distraction at the osteotomy line. 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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