FDA.reportPublic FDA data

SL Tissue Blade 55 mm blunt anodised black

Primary DI
04251554151892
Brand
SL Tissue Blade 55 mm blunt anodised black
Company
medical bees GmbH
Model
MB1-10-851-55
Published
2026-05-19
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
04251554151892PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251554151892042515541518924251554151892

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. 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
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
04251554151953SL Lateral Muscle Blade 30 mm short teeth, anodised natural MB1-10-852-302026-05-19

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Primary DI, Brand, Company table
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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
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00190776421649MillenniumAvalign Technologies, Inc.GAD2026-06-23
00190776421670MillenniumAvalign Technologies, Inc.GAD2026-06-23
00810158211292PRINCETONPrinceton Medical Group, Inc.GAD2026-06-23
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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