AccessGUDID - DEVICE: AESCULAP (04046955075805)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: MB599R
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: MB599R
Company Name: AESCULAP, INC.

Primary DI Number: 04046955075805
Issuing Agency: GS1
Commercial Distribution End Date: November 13, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 082594540 *Terms of Use

Device Description: MC IVOR Ring Retractor, blade, left, Fig. 3, depth: 28 mm, width: 77 mm, non-sterile, reusable

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?
35085	Mouth gag, adjustable, reusable	A mechanical device with adjustable parts intended to be placed between the teeth of the upper and lower jaws of a patient to maintain an open oral cavity, typically during emergent placement of an artificial airway or for an oral/dental surgical intervention. Also known as a jaw spreader, it is available in various designs having support structures that force and/or hold the jaws apart; e.g., it may be designed with flat, pivoted blades that angle outward when adjusted; or it may have two parallel plates that move apart with adjustments to a centre screw; or it may have a scissors-like design with pivoted, self-retaining, notched blades at the distal end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KBN	GAG, MOUTH

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: 9ff9a5c4-96b0-414c-85f5-9aab435d21c1
Public Version Date: November 14, 2024
Public Version Number: 2
DI Record Publish Date: May 06, 2020