Himplant Pre-Formed Penile Silicone Block

GUDID B097IMD009XXL1

Silicone-block tissue reconstructive material

Primary Device ID	B097IMD009XXL1
NIH Device Record Key	5a0866a1-5e37-4ede-9a43-08d3f45d2a7f
Commercial Distribution Status	In Commercial Distribution
Brand Name	Himplant Pre-Formed Penile Silicone Block
Version Model Number	Extra Extra Large - Semi Soft
Company DUNS	080156251
Company Name	INTERNATIONAL MEDICAL DEVICES, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	MR Safe
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
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

Device Issuing Agency	Device ID
HIBCC	B097IMD009XXL1 [Primary]

MIB	Elastomer, Silicone Block

Steralize Prior To Use	false
Device Is Sterile	true

B097IMD009XXL1	Extra Extra Large - Semi Soft
B097IMD009XLO1	Extra Large - Extra Long - Semi Soft
B097IMD009XL1	Extra Large - Semi Soft
B097IMD009LLO1	Large - Extra Long - Semi Soft
B097IMD009L1	Large - Semi Soft