AccessGUDID - DEVICE: ETHICON (10705031462533)

GUDID

Device Identifier (DI) Information

Brand Name: ETHICON
Version or Model: VSTAS1E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VSTAS1E
Company Name: ETHICON INC.

Primary DI Number: 10705031462533
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002144145 *Terms of Use

Device Description: VISTASEAL DUAL APPLICATOR

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?
64222	Haematological concentrate/haemostatic agent applicator cannula, open-surgery	A flexible or rigid tube intended to be used during an open surgical procedure for the administration of a haematological concentrate and/or haemostatic agent (e.g., thrombin, platelet concentrate, polysaccharide) to a bleeding surgical site, typically to facilitate haemostasis and healing, in conjunction with an applicator such as a syringe/plunger [not included]. It may have a single channel, to administer one product, or dual channels for co-administration of two different agents simultaneously; a channel for connection to a gas pump for spraying may also be incorporated. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MZM	Fibrin sealant preparation device

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 25783399-8fe8-4f62-b5f7-1c2c27441d9e
Public Version Date: November 16, 2023
Public Version Number: 4
DI Record Publish Date: October 01, 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
20705031462530	15	10705031462533	2023-11-15	Not in Commercial Distribution	BOX
30705031462537	120	10705031462533	2023-11-15	Not in Commercial Distribution	CASE
30705031466931	120	10705031462533		In Commercial Distribution	CASE
20705031466934	3	10705031462533		In Commercial Distribution	BOX

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)384-4266
Email: xxx@xxx.xxx

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