AccessGUDID - DEVICE: BioHorizons (00847236015893)

GUDID

Device Identifier (DI) Information

Brand Name: BioHorizons
Version or Model: BTUBEHOLDZ
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOHORIZONS IMPLANT SYSTEMS, INC

Primary DI Number: 00847236015893
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 967279910 *Terms of Use

Device Description: IntraSpin Tube Holder Replacement

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):	No
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?
15682	Centrifuge bucket/tube holder	A cylindrical or bucket-like device designed as a removable component of a centrifuge rotor head intended to safely contain (hold) a laboratory test tube or centrifuge tube containing a sample/specimen while the centrifuge is being operated at high speeds. It is typically made of metal or a strong synthetic polymer, has one or multiple positions for holding the sample/specimen tubes, and is open at the proximal end for their insertion. A protective screw-top cap or lid may be included to contain the contents of one or more sample/specimen tubes in the event of breakage. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ORG	Platelet And Plasma Separator For Bone Graft Handling

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
BK120048	0

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 175178e0-1330-467c-b4ab-dc2eb24095cb
Public Version Date: January 19, 2021
Public Version Number: 1
DI Record Publish Date: January 11, 2021

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

Customer Contact

[?]

No Customer Contact currently defined

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