AccessGUDID - DEVICE: COVAORTHO-NERVE (03760193182019)

GUDID

Device Identifier (DI) Information

Brand Name: COVAORTHO-NERVE
Version or Model: MCG 11 12 V
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: COVO12
Company Name: DILON TECHNOLOGIES FRANCE

Primary DI Number: 03760193182019
Issuing Agency: GS1
Commercial Distribution End Date: May 21, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 279346203 *Terms of Use

Device Description: Collagen Guided Healing Membrane

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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":	No
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?
34212	Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated	A bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JXI	Cuff, Nerve

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103081	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
Storage Environment Temperature: between 2 and 30 Degrees Celsius
Handling Environment Temperature: between 2 and 30 Degrees Celsius
Special Storage Condition, Specify: Dry place away from humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 25 Millimeter
Width: 15 Millimeter

Device Record Status

Public Device Record Key: d507ba53-65d4-40a0-b65a-2ceb90dc258b
Public Version Date: October 04, 2023
Public Version Number: 8
DI Record Publish Date: February 25, 2016