AccessGUDID - DEVICE: ARC (20653405001635)

GUDID

Device Identifier (DI) Information

Brand Name: ARC
Version or Model: C08-65
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C08-65
Company Name: Conmed Corporation

Primary DI Number: 20653405001635
Issuing Agency: GS1
Commercial Distribution End Date: February 21, 2024
Device Count: 6
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: Adjustable Retractor Cannula 8.0mm x 65mm

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?
52751	Haematological concentrate/haemostatic agent applicator cannula, endoscopic, single-use	A long flexible or rigid tube with an atraumatic tip intended to be used during an endoscopic/laparoscopic procedure to provide access 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 [not included]. It is designed to be inserted into the body percutaneously, via a port or endoscope/laparoscope. It may have a single or dual-channel(s) for administration of one or two agent(s); a channel for connection to a gas pump for spraying may be incorporated. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NBH	Accessories, arthroscopic

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: KEEP DRY

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3aa1b741-6d81-409b-a6dd-f2cb3b4ad8d8
Public Version Date: February 22, 2024
Public Version Number: 2
DI Record Publish Date: October 12, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10653405001638	1	20653405001635	2023-10-16	Not in Commercial Distribution	BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00653405001631 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(866)426-6633
Email: CustomerExperience@conmed.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES