AccessGUDID - DEVICE: ACE (00614950000005)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 0033134
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0033134
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950000005
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: ACE IMPLANT DRAPE 40"X52" STERILE 1/PKG 20PKG/CASE

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?
47781	General-purpose surgical drape, reusable, sterile	A sterile protective covering made of natural or synthetic materials, or both, designed to isolate a site of surgical incision or a surgical field from contamination (e.g., microbial, substance) in various clinical settings (e.g., in an operating room or catheterization laboratory). The device may also be used to protect a patient from heat/flame during a surgical procedure. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KKX	Drape, surgical

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 52 Inch
Width: 40 Inch

Device Record Status

Public Device Record Key: 83094b0e-a6dd-491d-b3b7-a7abc25a6ba8
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: October 21, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10614950000002	20	00614950000005		In Commercial Distribution	Tyvec Bag

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found 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: Yes
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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