AccessGUDID - DEVICE: AMD-RITMED SOLON (10686864049101)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED SOLON
Version or Model: 56701
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 56701
Company Name: AMD Medicom Inc

Primary DI Number: 10686864049101
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 COTTON TIP APPLICATORS 6 inch

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?
33722	General-purpose absorbent tip applicator/swab, single-use	A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXG	APPLICATOR, ABSORBENT TIPPED, STERILE

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

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 6 inch

Device Record Status

Public Device Record Key: dd2a66f4-8f08-4e49-b8d2-c0fbb7e89b06
Public Version Date: May 31, 2023
Public Version Number: 5
DI Record Publish Date: January 14, 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
20686864049108	10	30686864049105	2023-05-30	Not in Commercial Distribution	Outer Case
12686864049109	100	10686864049101	2023-02-13	Not in Commercial Distribution	Inner Box
30686864049105	100	10686864049101	2023-05-30	Not in Commercial Distribution	Box

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: mdasilva@medicom.ca

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

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