FDA.reportPublic FDA data

Carnegie Surgical LLC

Primary DI
G141521149260
Brand
Carnegie Surgical LLC
Company
Carnegie Surgical LLC
Model
521-14926
Catalog number
521-14926
Device description
BOZEMAN-HEANEY Needle Holder curved 10-1/2" (26cm) angled shanks, TC
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G141521149260PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(609) 249-2695info@carnegiesurgical.com

Regulatory Flags#

DUNS number
017636482
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G1415189430Carnegie Surgical LLC518-943518-9432026-10-12
G141548140010Carnegie Surgical LLC548-14001548-140012026-10-08
G141502302260Carnegie Surgical LLC502-30226502-302262026-10-07
G14150603010Carnegie Surgical LLC506-0301506-03012026-10-07
G14150603230Carnegie Surgical LLC506-0323506-03232026-10-07
G14150609010Carnegie Surgical LLC506-0901506-09012026-10-07
G141510457190Carnegie Surgical LLC510-45719510-457192026-10-07
G1415140730Carnegie Surgical LLC514-073514-0732026-10-07
G1415141510Carnegie Surgical LLC514-151514-1512026-10-07
G141514271180Carnegie Surgical LLC514-27118514-271182026-10-07
G141518123170Carnegie Surgical LLC518-12317518-123172026-10-07
G141518861000Carnegie Surgical LLC518-86100518-861002026-10-07
G141526051160Carnegie Surgical LLC526-05116526-051162026-10-07
G141530254210Carnegie Surgical LLC530-25421530-254212026-10-07
G141548140020Carnegie Surgical LLC548-14002548-140022026-10-07
G141548807040Carnegie Surgical LLC548-80704548-807042026-10-07
G141548807060Carnegie Surgical LLC548-80706548-807062026-10-07
G141549012180Carnegie Surgical LLC549-01218549-012182026-10-07
G141549966080Carnegie Surgical LLC549-96608549-966082026-10-07
G14155805410Carnegie Surgical LLC558-0541558-05412026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434892MillenniumAvalign Technologies, Inc.FHQ2026-10-14
B382SD9055891010Surgical DirectSurgical Direct, Inc.FHQ2026-10-13
00810220800621Adler Instrument CompanyAdler, Inc.FHQ2026-10-07
00192896123816Jacobson Needle HolderSONTEC INSTRUMENTS, INC.FHQ2026-10-06
B382SD905582180Surgical DirectSurgical Direct, Inc.FHQ2026-10-06
B382SD9056791090Surgical DirectSurgical Direct, Inc.FHQ2026-10-06
B382SD9056791170Surgical DirectSurgical Direct, Inc.FHQ2026-10-06
00724995279622V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286248V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995286286V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320164V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320263V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320317V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320324V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320331V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00724995320348V. MuellerSTERIS Deutschland GmbHFHQ2026-09-25
00840319759424Hayden MedicalHayden Medical, Inc.FHQ2026-09-04
00190776419684MillenniumAvalign Technologies, Inc.FHQ2026-08-25
00850083997007Suture SheildSUTURE SHIELD, INC.FHQ2026-08-03
B382SD45267180Surgical DirectSurgical Direct, Inc.FHQ2026-08-03
B382SD90557818E0Surgical DirectSurgical Direct, Inc.FHQ2026-07-29
00810143905076SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905083SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143905106SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143907193SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908671SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143908701SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909081SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909753SURGIPROSSurgipros, LLCFHQ2026-07-28
00810143909760SURGIPROSSurgipros, LLCFHQ2026-07-28