AccessGUDID - DEVICE: PRECISIONPASS (00801741031144)

GUDID

Device Identifier (DI) Information

Brand Name: PRECISIONPASS
Version or Model: 0118100
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0118100
Company Name: Davol Inc.

Primary DI Number: 00801741031144
Issuing Agency: GS1
Commercial Distribution End Date: November 28, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 001191048 *Terms of Use

Device Description: PrecisionPass Lap Delivery Device

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?
61372	Surgical mesh laparoscopic delivery/positioning device	A sterile, hand-held manual surgical instrument intended to facilitate delivery and/or positioning of surgical mesh for implantation during laparoscopic surgery to repair an abdominal hernia/fascial defect. It consists of a handle with mechanical features used to deploy the mesh, and a distal section for mounting the mesh (e.g., collapsible frame or hollow tube) which is inserted through a laparoscopic port for positioning for subsequent fixation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 15 Millimeter

Device Record Status

Public Device Record Key: 4c3eecc9-eb1a-4998-a310-506b06abb2fb
Public Version Date: October 22, 2024
Public Version Number: 3
DI Record Publish Date: May 17, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10801741031141	5	00801741031144	2021-11-28	Not in Commercial Distribution	CA

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)562-0027
Email: medical.services@bd.com

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