FDA.report

PrecisionPass Lap Delivery Device

Primary DI
10801741031141
Brand
PrecisionPass Lap Delivery Device
Company
Davol Inc.
Model
0118100
Catalog number
0118100
Device description
PrecisionPass Lap Delivery Device
Published
2015-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, general & plastic surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10801741031141PackageGS15In Commercial Distribution
00801741031144PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1080174103114110801741031141
00801741031144008017410311448017410311440801741031144

GMDN Terms

TermDefinition
Surgical mesh laparoscopic delivery/positioning deviceA 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.

Device Sizes

TypeValueUnit
Lumen/Inner Diameter15Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)562-0027medical.services@crbard.com
+1(800)562-0027medical.services@bd.com

Regulatory Flags

DUNS number
001191048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00801741233678GalaFLEXGP0103BDGP0103BD2025-09-25
00801741233685GalaFLEXGP0206BDGP0206BD2025-09-25
00801741233692GalaFLEXGP0208BDGP0208BD2025-09-25
00801741233708GalaFLEXGP0408BDGP0408BD2025-09-25
00801741233715GalaFLEXGP0608BDGP0608BD2025-09-25
00801741233722GalaFLEX LITEGFLT0207BDGFLT0207BD2025-09-25
00801741233739GalaFLEX LITEGFLT0515BDGFLT0515BD2025-09-25
00801741233746GalaFLEX LITEGFLT0520BDGFLT0520BD2025-09-25
00801741233753GalaFLEX LITEGFLT0013BDGFLT0013BD2025-09-25
00801741233760GalaFLEX LITEGFLT1020BDGFLT1020BD2025-09-25
00801741233777GalaFLEX LITEGFLT0015BDGFLT0015BD2025-09-25
00801741233784GalaFLEX LITEGFLT0017BDGFLT0017BD2025-09-25
00801741233791GalaFLEX LITEGFLT1520BDGFLT1520BD2025-09-25
00801741233814GalaFLEX LITEGFLT0019BDGFLT0019BD2025-09-25
00801741233821GalaFLEX LITEGFLT0022BDGFLT0022BD2025-09-25
00801741233838GalaFLEX LITEGFLT0025BDGFLT0025BD2025-09-25
00801741233852GalaFLEX LITEGFLT2025BDGFLT2025BD2025-09-25
00801741234019GalaFLEX LITEGFLT2530BDGFLT2530BD2025-09-25
00801741226519Phasix123000712300072025-02-24
00801741226533Phasix123000912300092025-02-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850016403179ActivSight Laparoscope 5.5mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403186ActivSight Laparoscope 10mm 30 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403254ActivSight Laparoscope 5.5mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00850016403261ActivSight Laparoscope 10mm 0 Degree NIRActiv Surgical, Inc.GCJ2026-05-26
00846159038644SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038651SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038668SCANLAN® InstrumentsSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038675SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038682SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038699SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038705SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038712SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
00846159038729SCANLAN® ClampSCANLAN INTERNATIONAL INCGCJ2026-05-22
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.GCJ2026-05-22
00190776417895MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418298MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418304MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00190776418311MillenniumAvalign Technologies, Inc.GCJ2026-03-23
00817428021551ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
10817428021558ModulapATC TECHNOLOGIES, INC.GCJ2026-03-20
00198506089527ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-03-13
10649111501326Sklar InstrumentsSKLAR CORPORATIONGCJ2026-03-12
00190776417840MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417857MillenniumAvalign Technologies, Inc.GCJ2026-03-11
00190776417864MillenniumAvalign Technologies, Inc.GCJ2026-03-11