AccessGUDID - DEVICE: Redfield IRC 2100 (00888937013252)

GUDID

Device Identifier (DI) Information

Brand Name: Redfield IRC 2100
Version or Model: RIRC-DT6210
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Coopersurgical, Inc.

Primary DI Number: 00888937013252
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 801895244 *Terms of Use

Device Description: Contact Tip/Sheath

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?
47757	Infrared tissue coagulation system handpiece	A hand-operated surgical device that is a component of an infrared tissue coagulation system and designed to activate and direct the infrared (IR) light applied to blood vessels and soft tissues for haemostasis and/or tissue removal. It typically houses an IR light bulb and is electrically connected to the system's control unit for power. This is a reusable device.	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 [?]
K974168	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 210 Millimeter
Outer Diameter: 6 Millimeter

Device Record Status

Public Device Record Key: 2615a0c1-2309-46fa-b2a5-3abca8f0743f
Public Version Date: February 28, 2024
Public Version Number: 5
DI Record Publish Date: September 20, 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
20888937013256	10	00888937013252		In Commercial Distribution

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

[?]

No Customer Contact currently defined

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