AccessGUDID - DEVICE: ACE (00614950013425)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 0031059
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0031059
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950013425
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 600
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: SANI-SLEEVE 2X60 NON-STERILE 20/SLV 30SLV/CA (600EA)

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?
12535	Medical equipment/instrument drape, single-use	A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LYU	ACCESSORY, SURGICAL APPAREL

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: No special storage conditions required

Clinically Relevant Size

[?]

Size Type Text
Length: 60 Inch

Device Record Status

Public Device Record Key: 048013d5-fe6f-401c-bb27-ddc92178fc31
Public Version Date: September 11, 2024
Public Version Number: 4
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: 10614950013422 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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES