AccessGUDID - DEVICE: Tapestry Biointegrative Implant (00810063820084)

GUDID

Device Identifier (DI) Information

Brand Name: Tapestry Biointegrative Implant
Version or Model: EM-A004-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: EM-A004-01
Company Name: Embody, Inc.

Primary DI Number: 00810063820084
Issuing Agency: GS1
Commercial Distribution End Date: April 05, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 079544913 *Terms of Use

Device Description: Tapestry Biointegrative Implant Insertion Sleeve

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61545	Extra-gynaecological surgical mesh, biologic-polymer composite	A partially-bioabsorbable, implantable material (e.g., flat sheet) made from both a bioabsorbable animal-derived biologic (e.g., porcine collagen) and a non-bioabsorbable synthetic polymer (e.g., polypropylene) intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. It may also be intended as a short-term scaffold for tissue regeneration. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201572	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Width: 70 Millimeter
Height: 50 Millimeter

Device Record Status

Public Device Record Key: d3084cb1-46c4-41c0-a43e-ce65c00adfe7
Public Version Date: May 30, 2025
Public Version Number: 5
DI Record Publish Date: April 05, 2022