TAPESTRY BIointegrative Implant with Insertion Sleeve

GUDID 00810063820008

Embody, Inc.

Multi-purpose surgical mesh, biologic-polymer composite

Primary Device ID	00810063820008
NIH Device Record Key	f9eeb171-a7f1-47f8-9dc0-b61be1e257b4
Commercial Distribution Status	In Commercial Distribution
Brand Name	TAPESTRY BIointegrative Implant with Insertion Sleeve
Version Model Number	TP-7050-02
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	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com
Phone	18337490981
Email	customercare@embody-inc.com

Device Dimensions

Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 Millimeter
Width	70 Millimeter
Height	50 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	00810063820008 [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

Devices Manufactured by Embody, Inc.

00810063820473 - TAPESTRY Biointegrative Implant with Introducer, w/ Cannula	2024-02-19
00810063820480 - TAPESTRY Biointegrative Implant with Introducer, w/ Cannula	2024-02-19
00810063820510 - TAPESTRY RC Biointegrative Implant System	2024-02-19 Disposable kit
00810063820527 - TAPESTRY RC Biointegrative Implant System	2024-02-19 Disposable kit
00810063820497 - TAPESTRY RC Biointegrative Implant System	2023-10-11 Disposable kit
00810063820503 - TAPESTRY RC Biointegrative Implant System	2023-10-11 Disposable kit
00810063820459 - TAPESTRY Biointegrative Implant with Introducer	2023-09-29 TAPESTRY Biointegrative Implant with Introducer, Anterior, 26mm x 26mm
00810063820466 - TAPESTRY Biointegrative Implant with Introducer	2023-09-29 TAPESTRY Biointegrative Implant with Introducer, Lateral, 26mm x 26mm