AccessGUDID - DEVICE: BioBrace 5mm (00860006566708)

GUDID

Device Identifier (DI) Information

Brand Name: BioBrace 5mm
Version or Model: BB5X250
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BB5X250
Company Name: Biorez, Inc.

Primary DI Number: 00860006566708
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081048222 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
60907	Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial	A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OWW	Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon
OWY	Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203267	000

Device Exempt from Premarket Submission: No 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
Handling Environment Temperature: between 0 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f2d659ba-db4f-4511-ae82-52702a77ff33
Public Version Date: October 04, 2023
Public Version Number: 3
DI Record Publish Date: May 24, 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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 833 324 6739
Email: info@biorez.com

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