AccessGUDID - DEVICE: Novo Surgical (00842331122347)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: OB6461-47
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331122347
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: Elliot Obstetrical Forceps, 15" (38.0 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:	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?
35082	Obstetrical forceps, reusable	A scissors-like obstetrical instrument intended specifically to assist the birth of the foetus during difficult vaginal births. It typically is designed with two curved blades are that are introduced separately and then connected to a handle to exert traction on the foetal head or to rotate the foetal head in order to facilitate its passage through the birth canal. It is made of metal. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDA	Forceps, Obstetrical

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
Length: 38 Centimeter

Device Record Status

Public Device Record Key: 88009732-227a-4e78-a647-2827e2b6fa09
Public Version Date: May 14, 2019
Public Version Number: 1
DI Record Publish Date: May 06, 2019

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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