AccessGUDID - DEVICE: Bi-Blade® (00812480011007)

GUDID

Device Identifier (DI) Information

Brand Name: Bi-Blade®
Version or Model: 2310BB
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2310BB
Company Name: MEDICAL INSTRUMENT DEVELOPMENT LABORATORIES, INC.

Primary DI Number: 00812480011007
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 790265227 *Terms of Use

Device Description: 27 Gauge BB Vitreous Cutter, 20 psi, Luer Anterior PVC Tubing Set, Sterile, Single Use

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?
59258	Vitrectomy system micro-cutting unit	A sterile, pneumatically-powered, hand-held cutting tool that incorporates a vitrectomy system handpiece, micro-tip and connecting tubing as a single unit, intended to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. The tubing transmits pneumatic power produced by a system generator to the handpiece which converts this into a mechanical oscillating-cutting action at the tip. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K153168	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
Storage Environment Temperature: between -40 and 70 Degrees Celsius
Storage Environment Humidity: between -40 and 70 Degrees Celsius
Handling Environment Temperature: between -40 and 70 Degrees Celsius
Handling Environment Humidity: between -40 and 70 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Needle Gauge: 27 Gauge

Device Record Status

Public Device Record Key: ec2ccd1f-549d-48ca-b7d9-957d91b7e143
Public Version Date: August 22, 2023
Public Version Number: 1
DI Record Publish Date: August 14, 2023