AccessGUDID - DEVICE: ELMED (00198506058455)

GUDID

Device Identifier (DI) Information

Brand Name: ELMED
Version or Model: 13-SSCB-W
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13-SSCB-W
Company Name: ELMED INCORPORATED

Primary DI Number: 00198506058455
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 049290364 *Terms of Use

Device Description: Stainless Steel Cutting Block Template, 8CM Tall, 6cm Wide at Base, 10cm Wide at the Top, 3/8” Thick, Surgical Grade Autoclavable Stainless Steel

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:	No
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?
16859	Dissection board	A flat, stiff device on which an object (a human or animal body or body part) is placed for support during dissection procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEN	Forceps, General & Plastic Surgery

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 29448d6f-0149-4a3e-bd3b-267020115ba7
Public Version Date: June 17, 2024
Public Version Number: 1
DI Record Publish Date: June 07, 2024