AccessGUDID - DEVICE: ACE (00614950022212)

GUDID

Device Identifier (DI) Information

Brand Name: ACE
Version or Model: 04941801
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 04941801
Company Name: ACE SURGICAL SUPPLY CO., INC.

Primary DI Number: 00614950022212
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 042763706 *Terms of Use

Device Description: BONE CORE SEPARATOR TOOL USE WITH TWO PIECE TREPHINE SS 17-4

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:	No
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?
63221	Bone trephine set	A collection of devices intended to be used to remove the necrotic tissue from the interior of the bone and fill in cancellous tissue and/or bone cement. It consists of one or more drills, tubes, handles, curettes, hammers and associated items (e.g., connectors, clamps), and may be used with a single-use tubing set. The components of the set are made of metal and are exchangeable. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

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
No Device Sizes

Device Record Status

Public Device Record Key: 221ee862-8ca4-42c3-9409-ea5ba6e979bc
Public Version Date: December 04, 2020
Public Version Number: 2
DI Record Publish Date: October 24, 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: 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: No
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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