AccessGUDID - DEVICE: MEDICOM (10686864869822)

GUDID

Device Identifier (DI) Information

Brand Name: MEDICOM
Version or Model: 4900
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4900
Company Name: AMD Medicom Inc

Primary DI Number: 10686864869822
Issuing Agency: GS1
Commercial Distribution End Date: January 26, 2022
Device Count: 20
Labeler D-U-N-S® Number*: 256880576 *Terms of Use

Device Description: SAFEGAUZE HEMOSTAT STERILE 4PLY WHITE

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":	No
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?
58059	Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial	A non-bioabsorbable device derived from plant polysaccharides [e.g., micro-dispersed oxidized cellulose (M-Doc), oxidized regenerated cellulose (ORC), calcium alginate] intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound, to facilitate local haemostasis; it does not contain an antimicrobial agent. It is available in various forms (e.g., gel, spray, powder, ointment, plaster/gauze pad, fibre/wool) that can be applied directly to the wound where it forms a seal until removed. The device is intended for use in the home or healthcare facility. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, wound, drug

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: Between 5°C and 40°C (i.e. between 41°F and 104°F)

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 0.75 x 0.75 Inch

Device Record Status

Public Device Record Key: 093f8df8-eb5d-435a-bb11-99eded4358f7
Public Version Date: January 27, 2022
Public Version Number: 8
DI Record Publish Date: September 11, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20686864869829	200	10686864869822	2022-01-26	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: 00686864869825 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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