AccessGUDID - DEVICE: Variant Retractor (B030SPO1152110)

GUDID

Device Identifier (DI) Information

Brand Name: Variant Retractor
Version or Model: SPO-115-211
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CAMBER SPINE TECHNOLOGIES, LLC

Primary DI Number: B030SPO1152110
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054205979 *Terms of Use

Device Description: Blade #2, 20mm x 110mm

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):	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?
63411	Ophthalmic surgical device handling forceps, reusable	A hand-held manual surgical instrument with blades designed to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing. It has a tweezers-like design (may be a micro/fine instrument) with two blades joined at the proximal (non-working) end which have variously designed tips at the working end, typically with a slot/groove to accept the ophthalmic device; it is made of metal and is available in various sizes. This is a reusable device intended to be sterilized prior to use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GAD	Retractor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: 21bf6341-b849-440a-8e0f-2280b7251b3e
Public Version Date: September 18, 2023
Public Version Number: 2
DI Record Publish Date: November 03, 2022