AccessGUDID - DEVICE: NEOVEIL (04973077713776)

GUDID

Device Identifier (DI) Information

Brand Name: NEOVEIL
Version or Model: NV-ET-M60E-3
Commercial Distribution Status: In Commercial Distribution
Catalog Number: NV-ET-M60E-3
Company Name: GUNZE LIMITED

Primary DI Number: 04973077713776
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694678546 *Terms of Use

Device Description: NEOVEIL Staple Line Reinforcement is composed of a biodegradable synthetic polymer, polyglycolic acid(PGA) and is offered as a nonwoven surgical mesh configured into sleeves. The device is applied to the surgical site via a mechanical stapler with two jaws, where one piece of the sleeve is slid over each jaw of the stapler. This is accomplished by attaching a similar-sized piece of nonabsorbable elastic knit to the PGA felt that is held together by means of PGA tacking threads. After deployment of the tube type reinforcement material, the non-degradable elastic knits, comprised of polyurethane and nylon, are removed and discarded along with the PGA tacking sutures. The PGA material is dyed with D&C Green No.6.

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?
44688	Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable	An implantable material (e.g., flat sheet) made from a bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] 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
OXC	Mesh, Surgical, Absorbable, Staple Line Reinforcement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221487	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: less than 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Millimeter
Width: 17 Millimeter

Device Record Status

Public Device Record Key: a20c82dc-53aa-4645-924e-6be68dcdcf61
Public Version Date: April 04, 2023
Public Version Number: 1
DI Record Publish Date: March 27, 2023