FDA.reportPublic FDA data

Sellors - Nut & Bolt (Pair)

Primary DI
05056405527289
Brand
Sellors - Nut & Bolt (Pair)
Company
PLATTS & NISBETT LIMITED
Model
PN2843
Catalog number
PN2843
Published
2025-08-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05056405527289PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056405527289050564055272895056405527289

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
290712512
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
05056405508578Charnley Femoral Prosthesis PusherPN2670PN26702026-02-11
05056405503566Nylon Head Impactor for Femoral Head (spare head for femoral head impactor)PN04752023-09-19
05056405502064Femoral Head Impactor, 204mm O/LPN02832023-09-18
05056405500152Retractor - Travers, CurvedPN0016PN00162025-09-10
05056405520662Sellors KeyPN1831PN18312025-08-27
05056405526398Sellors Retractor Small Blade (Pair)PN2710PN27102025-08-27
05056405526404Sellors Retractor Medium Blade (Pair)PN2711PN27112025-08-27
05056405526411Sellors Retractor Large Blade (Pair)PN2712PN27122025-08-27
05056405500770Forceps - Lincoln DissectingPN0104PN01042025-07-22
05056405509179Osteotome - Capener, Straight - 6mm Width with Green Soft Grip HandlePN3113PN31132025-05-21
05056405503986Retractor - JuniperPN05572025-01-21
05056405524103Forceps - Rongeur for Cement Extraction (Slide measures 205mm) - 20mm Jaw Width PN23212024-12-16
05056405514135Purse String Forceps, 270mm O/L, 55mm JawPN11992024-12-11
05056405500381Sellors RetractorPN00412024-11-07
05056405501203Murphy Skid Bone LeverPN01652024-10-04
05056405502880Finch Excision Clamp, Hollow Jaw, 235mm O/L, 95mm JawPN03902024-04-15
05056405504235Smith Petersen Osteotome, Curved, 205mm O/L, 13mm Width PN06022024-03-07
05056405508868SPAIRE Hohmann Retractor, Angled, 18mm PN29352023-10-23
05056405508875SPAIRE Iliac Wing RetractorPN29362023-10-23
05056405508882SPAIRE T Handle Retractor with Ischial/Iliac PinsPN29372023-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190471NAPACIFIC INSTRUMENTS, INC.GAD2026-07-09
00888937033663ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00888937033670ONETRAC™Coopersurgical, Inc.GAD2026-07-09
00841536148473ThompsonThompson Surgical Instruments, Inc.GAD2026-07-08
00850083275341Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275570Intrace USAPILOTIS TECH LLCGAD2026-07-03
00850083275969Intrace USAPILOTIS TECH LLCGAD2026-07-03
B8035202680ORTHOMEDORTHO-MED, INC.GAD2026-06-26
00190776421748MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421809MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421816MillenniumAvalign Technologies, Inc.GAD2026-06-24
00190776421830MillenniumAvalign Technologies, Inc.GAD2026-06-24
00192896123540Green RetractorSONTEC INSTRUMENTS, INC.GAD2026-06-24
00810220800447Adler Instrument CompanyAdler, Inc.GAD2026-06-24
00190776421649MillenniumAvalign Technologies, Inc.GAD2026-06-23
00190776421670MillenniumAvalign Technologies, Inc.GAD2026-06-23
00810158211292PRINCETONPrinceton Medical Group, Inc.GAD2026-06-23
00348783011456Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
00348783011463Premier Sawyer RetractorPREMIER DENTAL PRODUCTS COMPANYGAD2026-06-10
008401944956533P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956603P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956773P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
008401944956843P Small-Mini Frag SystemORTHOPEDIATRICS CORP.GAD2026-06-10
05060212055323Silicone Bands 2.16mm x 110mm dia x 3DTR MEDICAL LIMITEDGAD2026-06-10
00198506091339ELMED INCORPORATEDELMED INCORPORATEDGAD2026-06-09
00840277133670Innomed, Inc.INNOMED, INC.GAD2026-06-09
04049047155324GimmiGimmi GmbHGAD2026-06-08
G453PM1580030BC0PEAK MEDICALPeak Medical Distribution Inc.GAD2026-06-08
00846159040524SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04
00846159040531SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-04