AccessGUDID - DEVICE: ACE (00614950013517)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 0031402
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0031402
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950013517
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 50
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: ACE IRRIGATION SET 67" STERILE L/F 50/CA

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):	Yes
Over the Counter (OTC):	No
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?
64257	Surgical instrument irrigation channel	A length of invasive flexible or semi-flexible tube designed to be attached to a surgical instrument (e.g., surgical stapler) to direct irrigation fluids to the surgical site; it may in addition be intended to allow for introduction of air to facilitate procedures such as staple line leak testing, however it is not intended for medical gas insufflation or suction. It is intended to be used in combination with devices that do not have an integrated irrigation channel. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FPK	Tubing, fluid delivery

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: No special storage conditions required

Clinically Relevant Size

[?]

Size Type Text
Length: 67 Inch

Device Record Status

Public Device Record Key: 17d3f112-6838-4fc5-ab82-6d00c139e54c
Public Version Date: October 24, 2019
Public Version Number: 1
DI Record Publish Date: October 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
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 10614950013514 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
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: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(508)588-3100 ext: 214
Email: ritaknight@acesurgical.com

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