FDA.reportPublic FDA data

Norfolk & Norwich Retractor, Heavy Rack, 220mm O/L, 50mm Blade Depth, 4x5 Blunt

Primary DI
05056405500190
Brand
Norfolk & Norwich Retractor, Heavy Rack, 220mm O/L, 50mm Blade Depth, 4x5 Blunt
Company
PLATTS & NISBETT LIMITED
Model
PN0021
Published
2023-09-21
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
05056405500190PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05056405500190050564055001905056405500190

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
05056405527289Sellors - Nut & Bolt (Pair)PN2843PN28432025-08-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776433161MillenniumAvalign Technologies, Inc.GAD2026-10-01
00190776432959MillenniumAvalign Technologies, Inc.GAD2026-09-30
00190776432997MillenniumAvalign Technologies, Inc.GAD2026-09-30
G1415180500Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141518555120Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141528202010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572105820Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G141572106810Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
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G14157211460Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157212010Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
G14157213040Carnegie Surgical LLCCarnegie Surgical LLCGAD2026-09-30
00190776432874MillenniumAvalign Technologies, Inc.GAD2026-09-29
00190776432515MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432591MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432621MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432638MillenniumAvalign Technologies, Inc.GAD2026-09-28
00190776432669MillenniumAvalign Technologies, Inc.GAD2026-09-28
00840329838829N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329838980N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839000N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00840329839017N/ABLACK & BLACK SURGICAL, INC.GAD2026-09-28
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24