AccessGUDID - DEVICE: AMD-RITMED (10686864041594)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED
Version or Model: 1004-AD
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1004-AD
Company Name: AMD Medicom Inc

Primary DI Number: 10686864041594
Issuing Agency: GS1
Commercial Distribution End Date: July 03, 2024
Device Count: 10
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: AMD-RITMED NEURO SPONGE DOUBLE STRUNG X-R DETECTABLE 1 X 3 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?
13702	Neurosurgical sponge	A sterile absorbent material intended to be used on the brain to remove blood and other fluids during an operation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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: Cool dry place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 X 3 Inch

Device Record Status

Public Device Record Key: 49de57dc-3bbf-4e0a-a920-92a89a8694cd
Public Version Date: July 04, 2024
Public Version Number: 2
DI Record Publish Date: January 15, 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
20686864041591	20	10686864041594	2024-07-03	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: 00686864041597 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: mkansou@medicom.ca

Phone: +5146366262
Email: mdasilva@medicom.ca

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