FDA.report

APEX 3D Total Ankle Replacement System

Primary DI
00889795064004
Brand
APEX 3D Total Ankle Replacement System
Company
PARAGON 28, INC.
Model
P10-951-TPR1
Catalog number
P10-951-TPR1
Device description
APEX 3D-PS Total Ankle Replacement System, Tibia Impaction Peg Punch, Right, Size 1
Published
2020-12-15
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
HTOREAMER

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889795064004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795064004008897950640048897950640040889795064004

GMDN Terms

TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when pressed into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. It is and is available in various cutting head sizes, and is not primarily intended for soft-tissue coring. 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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