AccessGUDID - DEVICE: AMD-RITMED (10686864046292)

GUDID

Device Identifier (DI) Information

Brand Name: AMD-RITMED
Version or Model: 78682
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 78682
Company Name: AMD Medicom Inc

Primary DI Number: 10686864046292
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2023
Device Count: 5
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: AMD-RITMED STICK SPONGE X-RAY DETECTABLE 7/8 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?
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). 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: 7/8 Inch

Device Record Status

Public Device Record Key: 461df2f3-f637-4b9a-b8db-d9d12dd8ca3f
Public Version Date: August 31, 2023
Public Version Number: 3
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
20686864046299	20	10686864046292	2023-08-30	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: 00686864046295 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
Email: amdudi@medicom.ca

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

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