AccessGUDID - DEVICE: APOLLO (00653405051681)

GUDID

Device Identifier (DI) Information

Brand Name: APOLLO
Version or Model: 050054
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 050054
Company Name: Conmed Corporation

Primary DI Number: 00653405051681
Issuing Agency: GS1
Commercial Distribution End Date: October 21, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: APOLLO Papillotome

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?
61874	Open-surgery electrosurgical electrode, monopolar, single-use	An invasive, monopolar, electrical conductor intended to be attached to an appropriate handle/handpiece (not included) to deliver electrosurgical current directly to tissues for cutting/coagulation during an open surgical procedure. It may be available in a variety of forms (e.g., blade, ball, loop, needle, spatula) and requires a patient contact return electrode to complete the circuit. This is a single-use device intended to be used in a sterile condition.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNS	Unit, electrosurgical, endoscopic (with or without accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K982557	000

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
Handling Environment Temperature: between 16 and 27 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Handling Environment Humidity: between 30 and 75 Percent (%) Relative Humidity
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 8 Millimeter
Device Size Text, specify: 2.3 - 1.8 Millimeter Catheter Outer Diameter
Length: 30 Millimeter
Outer Diameter: 0.035 Inch
Device Size Text, specify: 7 - 5.5 French Catheter Outer Diameter
Outer Diameter: 0.889 Millimeter

Device Record Status

Public Device Record Key: 90e0212a-ee64-4741-b9ea-8042bf70c283
Public Version Date: October 21, 2020
Public Version Number: 5
DI Record Publish Date: January 04, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

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)237-0169
Email: CUSTOMER_SERVICE@CONMED.COM

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