AccessGUDID - DEVICE: Novo Surgical Inc. (00842331179303)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical Inc.
Version or Model: C96534-53
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C96534-53
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331179303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: ZENITH burford-finochietto rib spreader, curved arms, rack & pinion action, 2 pair detachable blades, stainless steel, spread: 8" (20.0 cm), arm length: 9 1/4" (21.0 cm), large blade: 2 1/2" (6.5 cm) wide x 3" (7.5 cm) deep, small blade: 2 1/2" (6.5 cm) wide x 1 3/4" (4.5 cm) deep

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?
62562	Hand-held surgical retractor, single-use	A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWS	Instruments, Surgical, Cardiovascular

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: 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: d18e32ec-053c-4ff1-a678-0cece03d7e63
Public Version Date: November 22, 2022
Public Version Number: 1
DI Record Publish Date: November 14, 2022