AccessGUDID - DEVICE: AMD-RITMED SOLON (10686864049170)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED SOLON
Version or Model: 58000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 58000
Company Name: AMD Medicom Inc

Primary DI Number: 10686864049170
Issuing Agency: GS1
Commercial Distribution End Date: May 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: AMD-RITMED SOLON INFANT TONGUE DEPRESSORS

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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?
42461	Tongue depressor, examination, single-use	A hand-held device used to displace the tongue to facilitate examination of the surrounding organs/tissues. It is typically a double-ended flat device with rounded working ends made of wood or plastic materials; it may be aromatic/flavoured to make then less intrusive. The device may be used in a healthcare facility, doctor's office, or in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMA	DEPRESSOR, TONGUE, NON-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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: less than 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 90a5aac9-26f2-41e2-8980-11c369a77649
Public Version Date: May 31, 2023
Public Version Number: 2
DI Record Publish Date: January 16, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
12686864049178	100	10686864049170	2023-05-30	Not in Commercial Distribution	Pack
20686864049177	10	12686864049178	2023-05-30	Not in Commercial Distribution	Outer Case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(514)636-6262 ext: 2309
Email: dabecassis@amdritmed.com

Phone: +1(514)636-6262
Email: amdudi@medicom.ca

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