AccessGUDID - DEVICE: SUTURE RING (00841668111659)

GUDID

Device Identifier (DI) Information

Brand Name: SUTURE RING
Version or Model: K30-1530
Commercial Distribution Status: In Commercial Distribution
Catalog Number: K30-1530
Company Name: KATENA PRODUCTS, INC.

Primary DI Number: 00841668111659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 085668598 *Terms of Use

Device Description: No description.

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?
62378	Vitrectomy sutureless lens holding ring, single-use	A sterile device in the form of a small circular ring designed to contain a selected vitrectomy sutureless lens (VSL) within its confines to hold the lens in the correct position directly to the front surface of the eye (corneal limbus) during vitreoretinal surgery. It is made of stainless steel or plastic and is available in a variety of adult and paediatric sizes. Depending upon the type, it is held in place with sutures or with connecting bands (one on either side of the ring) which are attached over the hooks of a self-retaining eyelid speculum or hooked onto a cannula. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HJK	Lens, Contact, Polymethylmethacrylate, Diagnostic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Temperature: between -20 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f4161798-d4de-4009-ad18-33984755e074
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 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
10841668111656	10	00841668111659		In Commercial Distribution	Box
20841668111653	10	10841668111656		In Commercial Distribution	Carton

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: (973) 989-1600
Email: globe@katena.com

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