Primary Device ID | M724CCB5T561 |
NIH Device Record Key | aa55dd00-40a0-413f-9f2e-11157bce578e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Gluteal Implant, Round, Textured, SDM |
Version Model Number | Size: 16.0cm x 16.0cm x 4.8cm |
Catalog Number | CCB5-T-56 |
Company DUNS | 784664955 |
Company Name | IMPLANTECH ASSOCIATES, INC. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | 1-800-733-0833 |
info@implantech.com |
Device Issuing Agency | Device ID |
---|---|
HIBCC | M724CCB5T561 [Primary] |
MIB | Elastomer, Silicone Block |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2019-11-14 |
Device Publish Date | 2017-08-07 |
M724CCB6T841 | Gluteal Implant |
M724CCB6T831 | Gluteal Implant |
M724CCB6T741 | Gluteal Implant |
M724CCB6T731 | Gluteal Implant |
M724CCB6T711 | Gluteal Implant |
M724CCB5T531 | Gluteal Implant |
M724CCB5T521 | Gluteal Implant |
M724CCB5T511 | Gluteal Implant |
M724CCB6T821 | Gluteal Implant |
M724CCB6T811 | Gluteal Implant |
M724CCB6T721 | Gluteal Implant |
M724CCB5T561 | Gluteal Implant |
M724CCB5T551 | Gluteal Implant |
M724CCB5T541 | Gluteal Implant |