AccessGUDID - DEVICE: ARISTA (00801741096808)

GUDID

Device Identifier (DI) Information

Brand Name: ARISTA
Version or Model: AM0010
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AM0010
Company Name: Davol Inc.

Primary DI Number: 00801741096808
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001191048 *Terms of Use

Device Description: Arista AH FlexiTip XL-R Applicator, 38 cm (15 in)

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?
60502	Atomizing surgical topical solution applicator	A sterile, hand-held manual surgical device intended to be used to apply a topical solution (e.g., medication) in the form of a mist/spray onto the mucosal or serosal surface of an exposed surgical site [e.g., during ear/nose/throat (ENT) or laparoscopic surgery]. It consists of a syringe connected to a cannula (e.g., via a Luer-lock), and contains a built-in atomizer. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LMG	Agent, absorbable hemostatic, non-collagen based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P050038	023

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
Length: 38 Centimeter

Device Record Status

Public Device Record Key: 9b5d672b-bae9-4e59-88df-8128dc0c7a20
Public Version Date: October 22, 2024
Public Version Number: 4
DI Record Publish Date: January 25, 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
10801741096805	10	00801741096808		In Commercial Distribution	CA

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)562-0027
Email: medical.services@bd.com

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