FDA.report

Bent Passing Needle Kit

Primary DI
90841823100743
Brand
Bent Passing Needle Kit
Company
AD-TECH MEDICAL INSTRUMENT CORPORATION
Model
BPNK1-10X
Catalog number
BPNK1-10X
Published
2021-08-09
Public version status
New
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
HWQPASSER

Product Code Classifications

CodeDeviceSpecialtyClass
HWQPasserOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
90841823100743PackageGS12In Commercial Distribution
00841823100740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
9084182310074390841823100743
00841823100740008418231007408418231007400841823100740

GMDN Terms

TermDefinition
Wire/ligature passer, reusableA hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00To be stored and used within typical hospital/office room ambient temperature and humidity conditions

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)776-1555sales@adtechmedical.com

Regulatory Flags

DUNS number
174813410
Device count
1
DM exempt
false
Premarket exempt
true
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
00841823110848Ad-Tech Macro Depth ElectrodeSR12R-SP05X-0BHSR12R-SP05X-0BH2026-02-23
00841823110855Ad-Tech Macro Depth ElectrodeSR08R-SP05X-0BHSR08R-SP05X-0BH2026-02-23
00841823110862Ad-Tech Macro Depth ElectrodeSR08R-SP21X-0C3SR08R-SP21X-0C32026-02-23
00841823110879Ad-Tech Macro Depth ElectrodeSR08R-SP61X-0C3SR08R-SP61X-0C32026-02-23
00841823110886Ad-Tech Macro Depth ElectrodeSR10R-SP05X-0BHSR10R-SP05X-0BH2026-02-23
00841823110893Ad-Tech Macro Depth ElectrodeSR10R-SP21X-0C3SR10R-SP21X-0C32026-02-23
00841823110909Ad-Tech Macro Depth ElectrodeSR10R-SP61X-0C3SR10R-SP61X-0C32026-02-23
00841823110916Ad-Tech Macro Depth ElectrodeSR12R-SP21X-0C3SR12R-SP21X-0C32026-02-23
00841823110923Ad-Tech Macro Depth ElectrodeSR12R-SP61X-0C3SR12R-SP61X-0C32026-02-23
00841823109996SIGNUM Connection System Cable1L-JBL-2DIN2025-12-09
00841823110008SIGNUM Connection System Cable1L-JBL-4DIN2025-12-09
00841823110015SIGNUM Connection System Cable1L-JBL-6DIN2025-12-09
00841823110039SIGNUM Connection System Cable1L-JBL-8DIN2025-12-09
00841823110053SIGNUM Connection System Cable1L-JBL-10DIN2025-12-09
00841823110060SIGNUM Connection System Cable1L-JBL-12BDIN2025-12-09
00841823110077SIGNUM Connection System Cable1L-JBL-14BDIN2025-12-09
00841823110084SIGNUM Connection System Cable1L-JBL-16DIN2025-12-09
00841823110091SIGNUM Connection System Cable1L-JBL-16BDIN2025-12-09
00841823110107SIGNUM Connection System Cable1L-JBL-20DIN2025-12-09
00841823110114SIGNUM Connection System Cable1L-JBL-24BDIN2025-12-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850067560173LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560180LaproCloseSurgical Principals, IncHWQ2025-12-11
00850067560197LaproCloseSurgical Principals, IncHWQ2025-12-11
00842188130243Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130250Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130267Shuttle PinTrimed, INC.HWQ2025-07-16
00842188130212Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130229Shuttle PinTrimed, INC.HWQ2025-07-08
00842188130236Shuttle PinTrimed, INC.HWQ2025-07-08
00840277409935P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409942P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
00840277409959P28 NeedleRIVERPOINT MEDICAL, LLCHWQ2025-05-29
10810128461075AC Slider NeedleT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846117425° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846118125° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846119845° Right, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846120445° Left, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
1081012846121190° Tight Curve, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461228Crescent, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
10810128461235Straight, Champion®+ Slider with Nitinol Passing WireT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHWQ2025-05-28
00816342025539ProPassPARCUS MEDICAL LLCHWQ2025-04-29
00816342025546ProPassPARCUS MEDICAL LLCHWQ2025-04-29
00816342025553ProPassPARCUS MEDICAL LLCHWQ2025-04-29
10888277393721MEDLINEMEDLINE INDUSTRIES, INC.HWQ2025-04-17
10080196384808MEDLINEMEDLINE INDUSTRIES, INC.HWQ2025-02-21
10888277354449MEDLINEMEDLINE INDUSTRIES, INC.HWQ2025-02-21
10888277355231MEDLINEMEDLINE INDUSTRIES, INC.HWQ2025-02-21
10888277355316MEDLINEMEDLINE INDUSTRIES, INC.HWQ2025-02-21
10888277355323MEDLINEMEDLINE INDUSTRIES, INC.HWQ2025-02-21
10888277376236MEDLINEMEDLINE INDUSTRIES, INC.HWQ2025-02-21