AccessGUDID - DEVICE: RCM6 Resorbable Collagen Membrane (00614950008155)

GUDID

Device Identifier (DI) Information

Brand Name: RCM6 Resorbable Collagen Membrane
Version or Model: T5093000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5093000
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950008155
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: *SPECIAL ORDER* COLLAGEN DNTL MEMBRANE 20X30MM RESORB STRL

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?
48709	Enterovirus neutralizing antibody (serotypes 68-71) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of neutralizing antibodies to one or multiple enteroviruses from serotypes 68-71 in a clinical specimen, using enterovirus antigens of known specificity.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NPL	Barrier, animal source, intraoral

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 20 Millimeter
Length: 30 Millimeter

Device Record Status

Public Device Record Key: 253dde8d-88b7-45cb-80d1-3dcde095a930
Public Version Date: March 10, 2021
Public Version Number: 3
DI Record Publish Date: January 18, 2016