AccessGUDID - DEVICE: Vitrectomy Infusion Sleeve (00632307001567)

GUDID

Device Identifier (DI) Information

Brand Name: Vitrectomy Infusion Sleeve
Version or Model: PD505.06
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Peregrine Surgical, Llc

Primary DI Number: 00632307001567
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622467348 *Terms of Use

Device Description: Vitrectomy Infusion Sleeve

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":	Yes
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?
16209	Ophthalmic tissue forceps, reusable	A hand-held ophthalmic surgical instrument designed to grasp, manipulate, compress, pull, or join eye and/or surrounding tissues during a surgical intervention. It is typically: 1) a one-piece instrument with a tweezers-like design having two conjoined blades with serrated tips at the working end; or 2) an instrument tip, with grasping blades at the distal end, that is inserted into a dedicated handle through which the blades are operated. It is typically made of high-grade stainless steel and plastic materials, and is available in various sizes. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HMX	CANNULA, OPHTHALMIC

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: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20 Gauge Needle
Needle Gauge: 20 Gauge

Device Record Status

Public Device Record Key: 2583dd13-f18d-46af-b1bb-04cfaa69af5d
Public Version Date: September 11, 2024
Public Version Number: 3
DI Record Publish Date: May 06, 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
10632307001564	5	00632307001567		In Commercial Distribution	Box

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: Yes
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(215)348-0456
Email: jayne@peregrine-surgical.com

Phone: +1(215)348-0456
Email: ryan@peregrine-surgical.com

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