AccessGUDID - DEVICE: Tobra Graft Compressor (00852360007027)

GUDID

Device Identifier (DI) Information

Brand Name: Tobra Graft Compressor
Version or Model: GC-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GC-100
Company Name: Tobra Medical, Inc.

Primary DI Number: 00852360007027
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 082014645 *Terms of Use

Device Description: Tobra Graft Compressor with mesh filtration basket

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":	Yes
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?
17131	Orthopaedic surgery tissue debris collector, single-use	A container designed to collect bone, cartilage, or adjacent soft-tissue debris/fragments (e.g., extracted by shaving or drilling procedures) during orthopaedic surgery (e.g., autograft transplantation). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYZ	Trap, Sterile Specimen

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
Special Storage Condition, Specify: Store in sterile double peal pouch in dry area

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7dd0217c-58f1-4cf8-b32f-848ed707029e
Public Version Date: May 26, 2023
Public Version Number: 1
DI Record Publish Date: May 18, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10852360007024	5	00852360007027		In Commercial Distribution	Carton

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

[?]

Phone: (866) 877-1505
Email: info@tobramedical.com

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