Calf Implant, Smooth SDM CCB7-S-81

GUDID M724CCB7S811

Calf Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material
Primary Device IDM724CCB7S811
NIH Device Record Key486cdccb-0ded-4a4a-a389-2b6c1a8fc084
Commercial Distribution StatusIn Commercial Distribution
Brand NameCalf Implant, Smooth SDM
Version Model NumberSize: 16.5cm x 7.2cm x 1.6cm
Catalog NumberCCB7-S-81
Company DUNS784664955
Company NameIMPLANTECH ASSOCIATES, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-733-0833
Emailinfo@implantech.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM724CCB7S811 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MIBElastomer, Silicone Block

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-11-13
Device Publish Date2017-08-07

On-Brand Devices [Calf Implant, Smooth SDM]

M724CCB7S811Calf Implant
M724CCB7S711Calf Implant
M724CCB7S511Calf Implant
M724CCB7S311Calf Implant
M724CCB7S211Calf Implant
M724CCB7S111Calf Implant
M724CCB7S911Calf Implant
M724CCB7S411Calf Implant

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.