DEVICE: PRECISIONPASS (00801741031144)

Device Identifier (DI) Information

PRECISIONPASS
0118100
Not in Commercial Distribution
0118100
Davol Inc.
00801741031144
GS1
November 28, 2021
1
001191048 *Terms of Use
PrecisionPass Lap Delivery Device
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

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
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FDA Product Code

[?]
Product Code Product Code Name
GCJ Laparoscope, general & plastic surgery
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Lumen/Inner Diameter: 15 Millimeter
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Device Record Status

4c3eecc9-eb1a-4998-a310-506b06abb2fb
October 22, 2024
3
May 17, 2015
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)562-0027
medical.services@bd.com
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