AccessGUDID - DEVICE: Avitene (00801741010491)

GUDID

Device Identifier (DI) Information

Brand Name: Avitene
Version or Model: 1010260
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1010260
Company Name: Davol Inc.

Primary DI Number: 00801741010491
Issuing Agency: GS1
Commercial Distribution End Date: November 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 001191048 *Terms of Use

Device Description: EndoAvitene Microfibrillar Collagen Hemostat in an Endoscopic Delivery System

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?
47201	Collagen haemostatic agent, non-antimicrobial	A bioabsorbable device derived from animal collagen (e.g., bovine or porcine collagen) designed to produce a rapid haemostasis through platelet activation/aggregation (which initiates the haemostatic cascade leading to a fibrin clot) during a surgical procedure. It is applied directly to the wound where it remains to be absorbed by the body; it is not dedicated to a specific anatomy/application and does not contain an antimicrobial agent. It may be supplied as a fibrillar or soft, pliable pad/sponge or loose fibres; it may be applied in combination with fibrin adhesives. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LMF	Agent, absorbable hemostatic, collagen based

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P800002	008

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: 50 Millimeter
Outer Diameter: 5 Millimeter
Width: 5 Millimeter
Depth: 1 Millimeter

Device Record Status

Public Device Record Key: a36f8543-1056-49b2-b29d-fb802b9fc76c
Public Version Date: October 22, 2024
Public Version Number: 5
DI Record Publish Date: September 12, 2014

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10801741010498	6	00801741010491	2021-11-28	Not 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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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