TAPESTRY Biointegrative Implant

GUDID 00810063820053

Embody, Inc.

Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Multi-purpose surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite Extra-gynaecological surgical mesh, biologic-polymer composite

Primary Device ID	00810063820053
NIH Device Record Key	2fdefad7-404c-4996-b37e-85318a145f10
Commercial Distribution Status	In Commercial Distribution
Brand Name	TAPESTRY Biointegrative Implant
Version Model Number	TP-4030-01
Company DUNS	079544913
Company Name	Embody, 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	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	true
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com
Phone	1-833-749-0981
Email	customercare@embody-inc.com

Device Dimensions

Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter
Width	40 Millimeter
Height	30 Millimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment Temperature	Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810063820053 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K201572

FDA Product Code

OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-11-30
Device Publish Date	2020-11-20

On-Brand Devices [TAPESTRY Biointegrative Implant]

00810063820053	TP-4030-01
00810063820046	TP-3030-01
00810063820022	TP-2550-01
00810063820015	TP-7025-02
00810063820060	Provided with Insertion Sleeve.
00810063820084	Tapestry Biointegrative Implant Insertion Sleeve
00810063820077	provided with insertion sleeve
00810063820039	TP-2030-01