FDA.reportPublic FDA data

Serrated Blade 50mm BB- Blade, Steel Black Coated

Primary DI
04251554124025
Brand
Serrated Blade 50mm BB- Blade, Steel Black Coated
Company
medical bees GmbH
Model
MB1-10-767-53
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
04251554124025PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251554124025042515541240254251554124025

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
342619239
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251554151991SL-Lateral Muscle Blade 50 mm short teeth, anodised dark violet MB1-10-852-502026-05-21
04251554122335Caspar screwdriver with black wheel handle (PPSU) 20 x 16 mm MB1-10-746-232026-05-19
04251554122403Spinal retractor Caspar drill long Drill length 14 mm, shaft Ø 8 mm Total lengthMB1-10-748-022026-05-19
04251554128689Depth Gauge Colour CodedMB1-10-860-602026-05-19
04251554135304Caliper Measuring range 160mm 47/100mmMB1-20-028-202026-05-19
04251554151809Bone graft forceps tip 7mmMB1-10-850-302026-05-19
04251554151816Bone graft holder total length 21.6cmMB1-10-850-402026-05-19
04251554151823Bone tamper Ø3mmMB1-10-851-032026-05-19
04251554151830Bone tamper Ø5mmMB1-10-851-052026-05-19
04251554151847Bone tamper Ø8mmMB1-10-851-082026-05-19
04251554151854SL Tissue Blade 30 mm blunt silver, anodised natural MB1-10-851-302026-05-19
04251554151861SL Tissue Blade 35mm blunt anodised dark blueMB1-10-851-352026-05-19
04251554151878SL Tissue Blade 40 mm blunt anodised dark red MB1-10-851-402026-05-19
04251554151885SL Tissue Blade 50 mm anodised dark violetMB1-10-851-502026-05-19
04251554151892SL Tissue Blade 55 mm blunt anodised black MB1-10-851-552026-05-19
04251554151908SL Tissue Blade 45 mm blunt anodised olive-green MB1-10-851-452026-05-19
04251554151915SL Tissue Blade 60 mm blunt anodised dark goldMB1-10-851-602026-05-19
04251554151922SL Tissue Blade 65 mm blunt anodised titanium MB1-10-851-652026-05-19
04251554151939SL Tissue Blade 70 mm blunt anodised yellow MB1-10-851-702026-05-19
04251554151946SL Tissue Blade 75 mm blunt anodised dark orange MB1-10-851-752026-05-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00198506092015ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00198506093685ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-22
00841731153104ARTEMIS FUZEVILEX LLCGAD2026-07-22
00841731153111ARTEMIS FUZEVILEX LLCGAD2026-07-22
B8038600980ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038600990ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803860120L0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8038601250ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018420ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018430ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039018840ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039030020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803903220020ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039401000ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601360ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601370ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601390ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B8039601400ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL97010ORTHOMEDORTHO-MED, INC.GAD2026-07-22
B803NL9701H0ORTHOMEDORTHO-MED, INC.GAD2026-07-22
00190776402174MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403317MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403324MillenniumAvalign Technologies, Inc.GAD2026-07-21
00190776403362MillenniumAvalign Technologies, Inc.GAD2026-07-21
00840183532185BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532192BR Surgical, LLCBR Surgical, LLCGAD2026-07-21
00840183532222BR Surgical, LLCBR Surgical, LLCGAD2026-07-21