AccessGUDID - DEVICE: Ace Medical (00840217906067)

GUDID

Device Identifier (DI) Information

Brand Name: Ace Medical
Version or Model: ECA-051
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ebner Medical, LLC

Primary DI Number: 00840217906067
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106135367 *Terms of Use

Device Description: Snapper lock for 20cc BD Syringe

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?
56636	Syringe lock	A small device designed to attach between the thumb rest of a syringe plunger and the top of the syringe barrel to lock the syringe in an open position to eliminate the need to manually hold the syringe plunger when generating a vacuum within the syringe. It is typically made of stainless steel and is available for different size syringes (e.g., 60 cc, 30 cc, 10 cc versions). It is typically used for the collection of adipose tissue from the patient or a container holding the tissue or other substances from plastic and reconstructive surgery, cosmetic surgery, or general surgery procedures. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MDM	Instrument, Manual, Surgical, General Use

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 28fb76d1-7ff5-4db9-a91d-aafa046f25d0
Public Version Date: January 29, 2024
Public Version Number: 3
DI Record Publish Date: January 11, 2022

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: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 8008220314
Email: info@acemedicalco.com

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