AccessGUDID - DEVICE: MACI Arthroscopic Instruments (00850037506002)

GUDID

Device Identifier (DI) Information

Brand Name: MACI Arthroscopic Instruments
Version or Model: 82032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: VERICEL CORPORATION

Primary DI Number: 00850037506002
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079745570 *Terms of Use

Device Description: MACI Applicator

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?
67306	Orthopaedic graft inserter, single-use	A hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., medical grade plastic, stainless steel or titanium (Ti)] used to advance the graft through a cannula, or a similar tubular access device (e.g., bone graft funnel), and into place; it is also available in a variety of sizes. It may additionally be supplied with accessories (e.g., swabs). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HXG	Tamp

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
No Device Sizes

Device Record Status

Public Device Record Key: f5512a53-8362-4bb9-8526-4fc593a11afb
Public Version Date: September 03, 2024
Public Version Number: 1
DI Record Publish Date: August 26, 2024

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: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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