AccessGUDID - DEVICE: Novo Surgical Inc. (00842331164088)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical Inc.
Version or Model: OB6318-93
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OB6318-93
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331164088
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: lateral vaginal retractor, open shanks, 2 1/2" (6.3 cm)

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?
58727	Vaginal rectocele reduction instrument	A non-sterile, hand-held, retractor-like device intended to be used to manually reduce a rectocele (herniation of lower bowel/rectum through a vaginal wall tear) during defecation to facilitate bowel emptying. It is intended to be used by direct application into the vagina by the patient during routine self-treatment to replace digital reduction and as an alternative to the more permanent pessary or surgical repair. It is typically made of plastic material and can be reused after appropriate cleaning.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDL	Retractor, Vaginal

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: 755cc3e5-1fd2-4d3f-8b8a-8a391fbc54ee
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 13, 2022

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1877-860-6686
Email: info@novosurgical.com

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