Silicone Block BLK-BSC-5

GUDID M724BLKBSC51

Silicone Block

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material
Primary Device IDM724BLKBSC51
NIH Device Record Keybf9f25e9-c597-4fca-b31b-a932f76cf3e4
Commercial Distribution StatusIn Commercial Distribution
Brand NameSilicone Block
Version Model NumberSize: 25.6mm x 22.6mm x 2.0mm
Catalog NumberBLK-BSC-5
Company DUNS784664955
Company NameIMPLANTECH ASSOCIATES, INC.
Device Count1
DM Exemptfalse
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
HIBCCM724BLKBSC51 [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 Number4
Public Version Date2019-11-14
Device Publish Date2015-09-24

On-Brand Devices [Silicone Block]

M724BLKBSC51Silicone Block
M724BLKBSC41Silicone Block
M724BLKBSC31Silicone Block
M724BLKBSC21Silicone Block
M724BLKBSC11Silicone Block

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