AccessGUDID - DEVICE: Novaclips (00852621004765)

GUDID

Device Identifier (DI) Information

Brand Name: Novaclips
Version or Model: N-10112NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N-10112NS
Company Name: VITALITEC INTERNATIONAL, INC.

Primary DI Number: 00852621004765
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 121464288 *Terms of Use

Device Description: Vascular Clamp

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":	Yes
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?
10873	Peripheral vascular clamp	A hand-held manual manual surgical instrument designed to directly compress a peripheral blood vessel typically for haemostasis (arrest or prevention of bleeding) during a procedure. It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel; it has long, slender blades at the working end that are either straight or angled. The device is available in various sizes. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	Clamp, Vascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K000098	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Radiation 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: 5a27bd6a-eac6-45eb-b4e9-f9c7b8396cfd
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 26, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10852621004762	100	00852621004765		In Commercial Distribution	Case

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: 5087476033
Email: eknupp@aol.com

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