AccessGUDID - DEVICE: REFLEX (30653405074810)

GUDID

Device Identifier (DI) Information

Brand Name: REFLEX
Version or Model: 530
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 530
Company Name: Conmed Corporation

Primary DI Number: 30653405074810
Issuing Agency: GS1
Commercial Distribution End Date: June 25, 2023
Device Count: 6
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: REFLEX ELC Endoscopic Clip Applier W/Titanium Clips, 10mm

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?
35649	Ligation clip, metallic	A metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy or a tissue bundle, for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries; a dedicated, disposable clip applier may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HBT	APPLIER, HEMOSTATIC CLIP

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K924929	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 32 Degrees Celsius
Storage Environment Temperature: between 50 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 10 Millimeter

Device Record Status

Public Device Record Key: d6613d77-3e4d-44e2-85f6-a2c7d308bb96
Public Version Date: June 26, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 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
20653405074813	6	30653405074810	2023-06-25	Not in Commercial Distribution	CARTON

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 00653405074819 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

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