FDA.reportPublic FDA data

Professional Surgical Instruments Co., Inc.

Primary DI
00853863007347
Brand
Professional Surgical Instruments Co., Inc.
Company
Professional Surgical Instruments Co., Inc.
Model
S14-207
Device description
"5"" Webster Needle Holder, Satin"
Published
2025-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10853863007344PackageGS1500In Commercial Distribution
00853863007347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085386300734410853863007344
00853863007347008538630073478538630073470853863007347

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and 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. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
197354343
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810058670595ProDentUSAGS12-126002026-03-27
00810097678316ProDentUSAGS12-122TC2026-03-27
00810097678323ProDentUSAGS12-126TC2026-03-27
00810097678330ProDentUSAGS12-127002026-03-27
00810097678347ProDentUSAGS12-127TC2026-03-27
00810097678354ProDentUSAGS12-129002026-03-27
00810097678361ProDentUSAGS12-129TC2026-03-27
00810097678378ProDentUSAGS12-132002026-03-27
00810097678385ProDentUSAGS12-132TC2026-03-27
00853863007040ProDentUSAGS12-122002026-03-27
00810058670540ProDentUSAGS12-065002026-02-18
00810058670557ProDentUSAGS12-067002026-02-18
00810058670564ProDentUSAGS12-105002026-02-18
00810097677043ProDentUSAGS12-070002026-02-18
00810097676947ProDentUSAGS12-005002026-02-17
00810097676954ProDentUSAGS12-005102026-02-17
00810097676961ProDentUSAGS12-0051TC2026-02-17
00810097676978ProDentUSAGS12-005TC2026-02-17
00810058670519ProDentUSAGS10-102002026-02-12
00810058670533Professional Surgical Instruments Co., Inc. 11-120002026-02-12

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Primary DI, Brand, Company table
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00810055250721Surgical DesignSurgical Design, Inc.FHQ2026-05-29
00810055250738Surgical DesignSurgical Design, Inc.FHQ2026-05-29
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