AccessGUDID - DEVICE: Silicone tubing, slit (04250381893555)

GUDID

Device Identifier (DI) Information

Brand Name: Silicone tubing, slit
Version or Model: 40-305-99
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 40-305-99
Company Name: Spiggle & Theis Medizintechnik GmbH

Primary DI Number: 04250381893555
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332893028 *Terms of Use

Device Description: for frame of McIvor mouth gag re-useable, 5 pieces

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":	Yes
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?
34004	Surgical instrument guard, reusable	A device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during an procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LRC	INSTRUMENT, ENT MANUAL SURGICAL

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: 2d5e5c85-53fc-425c-9fc2-1f980e4a441f
Public Version Date: October 04, 2022
Public Version Number: 1
DI Record Publish Date: September 26, 2022